Ignite Creation Date:
2025-12-24 @ 3:48 PM
Ignite Modification Date:
2025-12-25 @ 6:04 PM
Study NCT ID:
NCT00558792
Status:
COMPLETED
Last Update Posted:
2012-10-24
First Post:
2007-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Coronary MDCTA With Iopamidol Injection 370
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007479', 'term': 'Iopamidol'}], 'ancestors': [{'id': 'D014283', 'term': 'Triiodobenzoic Acids'}, {'id': 'D007463', 'term': 'Iodobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'usha.halemane@diag.bracco.com', 'phone': '609-514-2578', 'title': 'Usha Halemane, Executive Director of Medical Biometrics and Medical Writing', 'organization': 'Bracco Diagnostics Inc'}, 'certainAgreement': {'otherDetails': 'The results of the study may be presented during scientific symposia or published in a scientific journal only after review by Bracco in accordance with the guidelines set forth in the applicable publication or financial agreement.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Patients were monitored for any untoward medical occurrence from the time they signed the informed consent until 72 hours after the administration of iopamidol injection 370.', 'description': 'Only those adverse events that were reported after the injection of iopamidol injection 370 are presented.', 'eventGroups': [{'id': 'EG000', 'title': 'Isovue 370, 70 mL', 'description': 'iopamidol injection 370, 70 mL', 'otherNumAtRisk': 68, 'otherNumAffected': 15, 'seriousNumAtRisk': 68, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Isovue 370, 80 mL', 'description': 'iopamidol injection 370, 80 mL', 'otherNumAtRisk': 63, 'otherNumAffected': 14, 'seriousNumAtRisk': 63, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Isovue 370, 90 mL', 'description': 'iopamidol injection 370, 90 mL', 'otherNumAtRisk': 60, 'otherNumAffected': 13, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Feeling Hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 12.1'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 12.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 12.1'}, {'term': 'Injection Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 12.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}, {'units': 'Segments Present & Technically Adequate', 'counts': [{'value': '963', 'groupId': 'OG000'}, {'value': '865', 'groupId': 'OG001'}, {'value': '848', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Isovue 370, 70 mL', 'description': 'Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of \\>4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.'}, {'id': 'OG001', 'title': 'Isovue 370, 80 mL', 'description': 'Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \\>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.'}, {'id': 'OG002', 'title': 'Isovue 370, 90 mL', 'description': 'Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \\>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '949', 'groupId': 'OG000'}, {'value': '842', 'groupId': 'OG001'}, {'value': '841', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0099', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Immediately post dose', 'description': 'For all technically adequate coronary artery segments, each reader was to assess whether each segment was visualized to a quality that was adequate for accurate diagnosis of the presence and severity of stenosis. An adequate quality for the accurate diagnosis of the presence and severity of coronary artery stenosis was comprised of 2 basic features: 1) no more than mild blurring of the spatial distinction between the vessel wall and lumen, and 2) a readily visible distinction in image contrast between calcified plaque, enhanced vessel lumen, and uncalcified vessel wall or plaque.', 'unitOfMeasure': 'Segments Visualized Accurately', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Segments Present & Technically Adequate', 'denomUnitsSelected': 'Participants'}, {'type': 'PRIMARY', 'title': 'Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}, {'units': 'Segments', 'counts': [{'value': '1042', 'groupId': 'OG000'}, {'value': '950', 'groupId': 'OG001'}, {'value': '927', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Isovue 370, 70 mL', 'description': 'Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of \\>4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.'}, {'id': 'OG001', 'title': 'Isovue 370, 80 mL', 'description': 'Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \\>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.'}, {'id': 'OG002', 'title': 'Isovue 370, 90 mL', 'description': 'Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \\>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '1032', 'groupId': 'OG000'}, {'value': '924', 'groupId': 'OG001'}, {'value': '927', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Immediately post dose', 'description': 'For all technically adequate coronary artery segments, each reader was to assess whether each segment was visualized to a quality that was adequate for accurate diagnosis of the presence and severity of stenosis. An adequate quality for the accurate diagnosis of the presence and severity of coronary artery stenosis was comprised of 2 basic features: 1) no more than mild blurring of the spatial distinction between the vessel wall and lumen, and 2) a readily visible distinction in image contrast between calcified plaque, enhanced vessel lumen, and uncalcified vessel wall or plaque.', 'unitOfMeasure': 'Segments Visualized Accurately', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Segments', 'denomUnitsSelected': 'Participants'}, {'type': 'PRIMARY', 'title': 'Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}, {'units': 'Segments Present & Technically Adequate', 'counts': [{'value': '925', 'groupId': 'OG000'}, {'value': '826', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Isovue 370, 70 mL', 'description': 'Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of \\>4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.'}, {'id': 'OG001', 'title': 'Isovue 370, 80 mL', 'description': 'Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \\>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.'}, {'id': 'OG002', 'title': 'Isovue 370, 90 mL', 'description': 'Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \\>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '925', 'groupId': 'OG000'}, {'value': '824', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1212', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Immediately post dose', 'description': 'For all technically adequate coronary artery segments, each reader was to assess whether each segment was visualized to a quality that was adequate for accurate diagnosis of the presence and severity of stenosis. An adequate quality for the accurate diagnosis of the presence and severity of coronary artery stenosis was comprised of 2 basic features: 1) no more than mild blurring of the spatial distinction between the vessel wall and lumen, and 2) a readily visible distinction in image contrast between calcified plaque, enhanced vessel lumen, and uncalcified vessel wall or plaque.', 'unitOfMeasure': 'Segments Visualized Accurately', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Segments Present & Technically Adequate', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced Adverse Events With Incidence of 5% or Greater', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Isovue 370, 70 mL', 'description': 'iopamidol injection 370, 70 mL'}, {'id': 'OG001', 'title': 'Isovue 370, 80 mL', 'description': 'iopamidol injection 370, 80 mL'}, {'id': 'OG002', 'title': 'Isovue 370, 90 mL', 'description': 'iopamidol injection 370, 90 mL'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 72 hours post dose', 'description': 'Participants who received investigational product (iopamidol injection) and experienced an adverse event (AE). See Adverse Events module for further details.', 'unitOfMeasure': 'Participants who Experienced AE(s)', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Contrast Density (CD) Measurements, Off-Site Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Isovue 370, 70 mL', 'description': 'Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of \\>4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.'}, {'id': 'OG001', 'title': 'Isovue 370, 80 mL', 'description': 'Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \\>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.'}, {'id': 'OG002', 'title': 'Isovue 370, 90 mL', 'description': 'Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \\>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '372.806', 'spread': '90.5842', 'groupId': 'OG000'}, {'value': '398.255', 'spread': '82.3593', 'groupId': 'OG001'}, {'value': '418.197', 'spread': '97.4072', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0200', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Immediately post dose', 'description': 'For this assessment, each off-site reader was to place regions of interest (ROIs) into the lumens of the mid-portion of the left main coronary artery (LM) (segment number 5), and into the mid-portion of segment number 1 of the right coronary artery (RCA). The mean Hounsfield Units levels and standard deviations (SD) for those 2 ROIs were to be recorded by the reader.', 'unitOfMeasure': 'Hounsfield Units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Contrast Density (CD) Measurements, Off-Site Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Isovue 370, 70 mL', 'description': 'Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of \\>4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.'}, {'id': 'OG001', 'title': 'Isovue 370, 80 mL', 'description': 'Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \\>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.'}, {'id': 'OG002', 'title': 'Isovue 370, 90 mL', 'description': 'Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \\>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '364.784', 'spread': '78.2154', 'groupId': 'OG000'}, {'value': '396.291', 'spread': '85.7038', 'groupId': 'OG001'}, {'value': '413.665', 'spread': '86.0972', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0044', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Immediately post dose', 'description': 'For this assessment, each off-site reader was to place regions of interest (ROIs) into the lumens of the mid-portion of the left main coronary artery (LM) (segment number 5), and into the mid-portion of segment number 1 of the right coronary artery (RCA). The mean Hounsfield Units levels and standard deviations (SD) for those 2 ROIs were to be recorded by the reader.', 'unitOfMeasure': 'Hounsfield Units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Contrast Density (CD) Measurements, Off-Site Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Isovue 370, 70 mL', 'description': 'Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of \\>4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.'}, {'id': 'OG001', 'title': 'Isovue 370, 80 mL', 'description': 'Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \\>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.'}, {'id': 'OG002', 'title': 'Isovue 370, 90 mL', 'description': 'Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \\>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '363.071', 'spread': '85.7795', 'groupId': 'OG000'}, {'value': '383.841', 'spread': '96.8142', 'groupId': 'OG001'}, {'value': '406.206', 'spread': '91.9117', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0371', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Immediately post dose', 'description': 'For this assessment, each off-site reader was to place regions of interest (ROIs) into the lumens of the mid-portion of the left main coronary artery (LM) (segment number 5), and into the mid-portion of segment number 1 of the right coronary artery (RCA). The mean Hounsfield Units levels and standard deviations (SD) for those 2 ROIs were to be recorded by the reader.', 'unitOfMeasure': 'Hounsfield Units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Validity (Sensitivity and Specificity), Off-Site Reader 1 - Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}, {'units': 'Vessels', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Isovue 370, 70 mL', 'description': 'Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of \\>4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.'}, {'id': 'OG001', 'title': 'Isovue 370, 80 mL', 'description': 'Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \\>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.'}, {'id': 'OG002', 'title': 'Isovue 370, 90 mL', 'description': 'Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \\>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '63.6', 'groupId': 'OG000'}, {'value': '65.5', 'groupId': 'OG001'}, {'value': '77.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.2758', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Sensitivity between Doses', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.1', 'ciLowerLimit': '-11.4', 'ciUpperLimit': '39.6', 'pValueComment': 'Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3102', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Sensitivity between Doses', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.3', 'ciLowerLimit': '-11.1', 'ciUpperLimit': '35.6', 'pValueComment': 'Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8893', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Sensitivity between Doses', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.9', 'ciLowerLimit': '-24.6', 'ciUpperLimit': '28.4', 'pValueComment': 'Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Immediately post dose', 'description': 'For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of sensitivity \\[TP/(TP+FN)\\] is presented.', 'unitOfMeasure': 'Sensitivity (%)', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Vessels', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Number of participants with significant disease (\\>50% stenosis)'}, {'type': 'PRIMARY', 'title': 'Validity (Sensitivity and Specificity), Off-Site Reader 1 - Specificity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}, {'units': 'Vessels', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Isovue 370, 70 mL', 'description': 'Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of \\>4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.'}, {'id': 'OG001', 'title': 'Isovue 370, 80 mL', 'description': 'Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \\>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.'}, {'id': 'OG002', 'title': 'Isovue 370, 90 mL', 'description': 'Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \\>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.3', 'groupId': 'OG000'}, {'value': '95.2', 'groupId': 'OG001'}, {'value': '96.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.2511', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Specificity between Doses', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.7', 'ciLowerLimit': '-4.7', 'ciUpperLimit': '1.3', 'pValueComment': 'Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4985', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Specificity between Doses', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '-2.6', 'ciUpperLimit': '5.3', 'pValueComment': 'Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0693', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Specificity between Doses', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.1', 'ciLowerLimit': '-6.5', 'ciUpperLimit': '0.4', 'pValueComment': 'Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Immediately post dose', 'description': 'For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of specificity \\[TN/(TN+FP)\\] is presented.', 'unitOfMeasure': 'Specificity (%)', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Vessels', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Number of participants with significant disease (\\>50% stenosis)'}, {'type': 'PRIMARY', 'title': 'Validity (Sensitivity and Specificity), Off-Site Reader 2 - Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}, {'units': 'Vessels', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Isovue 370, 70 mL', 'description': 'Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of \\>4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.'}, {'id': 'OG001', 'title': 'Isovue 370, 80 mL', 'description': 'Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \\>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.'}, {'id': 'OG002', 'title': 'Isovue 370, 90 mL', 'description': 'Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \\>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '68.2', 'groupId': 'OG000'}, {'value': '79.3', 'groupId': 'OG001'}, {'value': '66.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.9104', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Sensitivity between Doses', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.5', 'ciLowerLimit': '-27.9', 'ciUpperLimit': '24.8', 'pValueComment': 'Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2857', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Sensitivity between Doses', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.6', 'ciLowerLimit': '-35.7', 'ciUpperLimit': '10.5', 'pValueComment': 'Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3664', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Sensitivity between Doses', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.1', 'ciLowerLimit': '-13.3', 'ciUpperLimit': '35.5', 'pValueComment': 'Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Immediately post dose', 'description': 'For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of sensitivity \\[TP/(TP+FN)\\] is presented.', 'unitOfMeasure': 'Sensitivity (%)', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Vessels', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Number of participants with significant disease (\\>50% stenosis)'}, {'type': 'PRIMARY', 'title': 'Validity (Sensitivity and Specificity), Off-Site Reader 2 - Specificity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}, {'units': 'Vessels', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Isovue 370, 70 mL', 'description': 'Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of \\>4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.'}, {'id': 'OG001', 'title': 'Isovue 370, 80 mL', 'description': 'Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \\>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.'}, {'id': 'OG002', 'title': 'Isovue 370, 90 mL', 'description': 'Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \\>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.5', 'groupId': 'OG000'}, {'value': '92.1', 'groupId': 'OG001'}, {'value': '90.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1322', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Specifcity between Doses', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.7', 'ciLowerLimit': '-8.7', 'ciUpperLimit': '1.2', 'pValueComment': 'Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.6381', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Specificity between Doses', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-6.9', 'ciUpperLimit': '4.2', 'pValueComment': 'Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3217', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Specificity between Doses', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.4', 'ciLowerLimit': '-7.2', 'ciUpperLimit': '2.4', 'pValueComment': 'Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Immediately post dose', 'description': 'For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of specificity \\[TN/(TN+FP)\\] is presented.', 'unitOfMeasure': 'Specificity (%)', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Vessels', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Number of participants with significant disease (\\>50% stenosis)'}, {'type': 'PRIMARY', 'title': 'Validity (Sensitivity and Specificity), Off-Site Reader 3 - Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}, {'units': 'Vessels', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Isovue 370, 70 mL', 'description': 'Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of \\>4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.'}, {'id': 'OG001', 'title': 'Isovue 370, 80 mL', 'description': 'Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \\>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.'}, {'id': 'OG002', 'title': 'Isovue 370, 90 mL', 'description': 'Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \\>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '59.1', 'groupId': 'OG000'}, {'value': '62.1', 'groupId': 'OG001'}, {'value': '66.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.5843', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Sensitivity between Doses', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.6', 'ciLowerLimit': '-19.6', 'ciUpperLimit': '34.7', 'pValueComment': 'Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7197', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Sensitivity between Doses', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.6', 'ciLowerLimit': '-20.5', 'ciUpperLimit': '29.7', 'pValueComment': 'Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8292', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Sensitivity between Doses', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.0', 'ciLowerLimit': '-24.1', 'ciUpperLimit': '30.1', 'pValueComment': 'Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Immediately post dose', 'description': 'For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of sensitivity \\[TP/(TP+FN)\\] is presented.', 'unitOfMeasure': 'Sensitivity (%)', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Vessels', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Number of participants with significant disease (\\>50% stenosis)'}, {'type': 'PRIMARY', 'title': 'Validity (Sensitivity and Specificity), Off-Site Reader 3 - Specificity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}, {'units': 'Vessels', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Isovue 370, 70 mL', 'description': 'Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of \\>4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.'}, {'id': 'OG001', 'title': 'Isovue 370, 80 mL', 'description': 'Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \\>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.'}, {'id': 'OG002', 'title': 'Isovue 370, 90 mL', 'description': 'Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of \\>4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.9', 'groupId': 'OG000'}, {'value': '91.5', 'groupId': 'OG001'}, {'value': '90.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0888', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Specificity between Doses', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.2', 'ciLowerLimit': '-9.0', 'ciUpperLimit': '0.7', 'pValueComment': 'Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7796', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Specificity between Doses', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-6.4', 'ciUpperLimit': '4.8', 'pValueComment': 'Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1662', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Specificity between Doses', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.4', 'ciLowerLimit': '-8.2', 'ciUpperLimit': '1.5', 'pValueComment': 'Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Immediately post dose', 'description': 'For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of specificity \\[TN/(TN+FP)\\] is presented.', 'unitOfMeasure': 'Specificity (%)', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Vessels', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Number of participants with significant disease (\\>50% stenosis)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Isovue 370, 70 mL', 'description': 'iopamidol injection 370, 70 mL'}, {'id': 'FG001', 'title': 'Isovue 370, 80 mL', 'description': 'iopamidol injection 370, 80 mL'}, {'id': 'FG002', 'title': 'Isovue 370, 90 mL', 'description': 'iopamidol injection 370, 90 mL'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients were enrolled from December 2007 to December 2009 in 17 investigational sites across the United States of America (USA), 2 investigational sites in Canada and 2 investigational sites in Italy. A blinded read of the images obtained during the study was performed in May 2010.', 'preAssignmentDetails': 'This was a Phase II, multicenter, prospective, double-blind, randomized, parallel-group comparison of 3 doses of iopamidol injection 370 when used for coronary MDCTA.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '191', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Isovue 370, 70 mL', 'description': 'iopamidol injection 370, 70 mL'}, {'id': 'BG001', 'title': 'Isovue 370, 80 mL', 'description': 'iopamidol injection 370, 80 mL'}, {'id': 'BG002', 'title': 'Isovue 370, 90 mL', 'description': 'iopamidol injection 370, 90 mL'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.7', 'spread': '8.85', 'groupId': 'BG000'}, {'value': '57.7', 'spread': '8.54', 'groupId': 'BG001'}, {'value': '58.7', 'spread': '9.25', 'groupId': 'BG002'}, {'value': '58.0', 'spread': '8.85', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '73', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '118', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '153', 'groupId': 'BG003'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-18', 'studyFirstSubmitDate': '2007-11-13', 'resultsFirstSubmitDate': '2012-08-13', 'studyFirstSubmitQcDate': '2007-11-14', 'lastUpdatePostDateStruct': {'date': '2012-10-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-09-18', 'studyFirstPostDateStruct': {'date': '2007-11-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 1', 'timeFrame': 'Immediately post dose', 'description': 'For all technically adequate coronary artery segments, each reader was to assess whether each segment was visualized to a quality that was adequate for accurate diagnosis of the presence and severity of stenosis. An adequate quality for the accurate diagnosis of the presence and severity of coronary artery stenosis was comprised of 2 basic features: 1) no more than mild blurring of the spatial distinction between the vessel wall and lumen, and 2) a readily visible distinction in image contrast between calcified plaque, enhanced vessel lumen, and uncalcified vessel wall or plaque.'}, {'measure': 'Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 2', 'timeFrame': 'Immediately post dose', 'description': 'For all technically adequate coronary artery segments, each reader was to assess whether each segment was visualized to a quality that was adequate for accurate diagnosis of the presence and severity of stenosis. An adequate quality for the accurate diagnosis of the presence and severity of coronary artery stenosis was comprised of 2 basic features: 1) no more than mild blurring of the spatial distinction between the vessel wall and lumen, and 2) a readily visible distinction in image contrast between calcified plaque, enhanced vessel lumen, and uncalcified vessel wall or plaque.'}, {'measure': 'Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 3', 'timeFrame': 'Immediately post dose', 'description': 'For all technically adequate coronary artery segments, each reader was to assess whether each segment was visualized to a quality that was adequate for accurate diagnosis of the presence and severity of stenosis. An adequate quality for the accurate diagnosis of the presence and severity of coronary artery stenosis was comprised of 2 basic features: 1) no more than mild blurring of the spatial distinction between the vessel wall and lumen, and 2) a readily visible distinction in image contrast between calcified plaque, enhanced vessel lumen, and uncalcified vessel wall or plaque.'}, {'measure': 'Contrast Density (CD) Measurements, Off-Site Reader 1', 'timeFrame': 'Immediately post dose', 'description': 'For this assessment, each off-site reader was to place regions of interest (ROIs) into the lumens of the mid-portion of the left main coronary artery (LM) (segment number 5), and into the mid-portion of segment number 1 of the right coronary artery (RCA). The mean Hounsfield Units levels and standard deviations (SD) for those 2 ROIs were to be recorded by the reader.'}, {'measure': 'Contrast Density (CD) Measurements, Off-Site Reader 2', 'timeFrame': 'Immediately post dose', 'description': 'For this assessment, each off-site reader was to place regions of interest (ROIs) into the lumens of the mid-portion of the left main coronary artery (LM) (segment number 5), and into the mid-portion of segment number 1 of the right coronary artery (RCA). The mean Hounsfield Units levels and standard deviations (SD) for those 2 ROIs were to be recorded by the reader.'}, {'measure': 'Contrast Density (CD) Measurements, Off-Site Reader 3', 'timeFrame': 'Immediately post dose', 'description': 'For this assessment, each off-site reader was to place regions of interest (ROIs) into the lumens of the mid-portion of the left main coronary artery (LM) (segment number 5), and into the mid-portion of segment number 1 of the right coronary artery (RCA). The mean Hounsfield Units levels and standard deviations (SD) for those 2 ROIs were to be recorded by the reader.'}, {'measure': 'Validity (Sensitivity and Specificity), Off-Site Reader 1 - Sensitivity', 'timeFrame': 'Immediately post dose', 'description': 'For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of sensitivity \\[TP/(TP+FN)\\] is presented.'}, {'measure': 'Validity (Sensitivity and Specificity), Off-Site Reader 1 - Specificity', 'timeFrame': 'Immediately post dose', 'description': 'For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of specificity \\[TN/(TN+FP)\\] is presented.'}, {'measure': 'Validity (Sensitivity and Specificity), Off-Site Reader 2 - Sensitivity', 'timeFrame': 'Immediately post dose', 'description': 'For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of sensitivity \\[TP/(TP+FN)\\] is presented.'}, {'measure': 'Validity (Sensitivity and Specificity), Off-Site Reader 2 - Specificity', 'timeFrame': 'Immediately post dose', 'description': 'For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of specificity \\[TN/(TN+FP)\\] is presented.'}, {'measure': 'Validity (Sensitivity and Specificity), Off-Site Reader 3 - Sensitivity', 'timeFrame': 'Immediately post dose', 'description': 'For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of sensitivity \\[TP/(TP+FN)\\] is presented.'}, {'measure': 'Validity (Sensitivity and Specificity), Off-Site Reader 3 - Specificity', 'timeFrame': 'Immediately post dose', 'description': 'For each technically adequate coronary artery, the readers assessed or excluded the presence of coronary artery stenoses. If more than one stenosis was present in a single vessel, the readers recorded the most significant stenosis. Based on a match or mismatch between computed tomographic angiography (CTA) and coronary angiography as assessed by the adjudicator, each vessel diagnosis by CTA was defined as true negative (TN), false positive (FP), false negative (FN), or true positive (TP) based on coronary angiography findings. Technical inadequacy by multi-detector CTA was counted as FN or FP depending on the diagnostic results from conventional angiography. The percentage (%) of specificity \\[TN/(TN+FP)\\] is presented.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Experienced Adverse Events With Incidence of 5% or Greater', 'timeFrame': 'up to 72 hours post dose', 'description': 'Participants who received investigational product (iopamidol injection) and experienced an adverse event (AE). See Adverse Events module for further details.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Determine the validity and compare the visualization of arterial segments obtained with 3 doses of iopamidol to determine dose for further investigation in future trials.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provide informed consent\n* At least 30 years of age\n* Weight less than 250 lbs\n* Known or suspected coronary artery disease and suspected to have significant coronary artery stenosis\n* Undergo MDCTA scan\n* Undergo coronary angiography within 2 weeks of MDCTA scan\n\nExclusion Criteria:\n\n* Hx of hypersensitivity to iodinated contrast agents\n* Known or suspected hyperthyroidism or pheochromocytoma\n* Renal impairment\n* History of coronary artery stent placement or bypass grafts\n* Unstable\n* Pregnant or lactating'}, 'identificationModule': {'nctId': 'NCT00558792', 'briefTitle': 'Coronary MDCTA With Iopamidol Injection 370', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bracco Diagnostics, Inc'}, 'officialTitle': 'A Phase II Multicenter Randomized Double Blind Dose Finding Study of Iopamidol Injection 370 in Multidetector Computed Tomographic Angiography (MDCTA) in Patients With Suspected Coronary Artery Stenosis', 'orgStudyIdInfo': {'id': 'IOP 108'}, 'secondaryIdInfos': [{'id': 'NCT00558792', 'type': 'REGISTRY', 'domain': 'clinicaltrials.gov'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Isovue 370, 70 mL', 'description': 'iopamidol injection 370, 70 mL', 'interventionNames': ['Drug: Isovue 370, 70 mL']}, {'type': 'EXPERIMENTAL', 'label': 'Isovue 370, 80 mL', 'description': 'iopamidol injection 370, 80 mL', 'interventionNames': ['Drug: Isovue 370, 80 mL']}, {'type': 'EXPERIMENTAL', 'label': 'Isovue 370, 90 mL', 'description': 'iopamidol injection 370, 90 mL', 'interventionNames': ['Drug: Isovue 370, 90 mL']}], 'interventions': [{'name': 'Isovue 370, 70 mL', 'type': 'DRUG', 'otherNames': ['Isovue'], 'description': '70 mL of iopamidol injection 370 injected at a rate of \\>=4 mL/second', 'armGroupLabels': ['Isovue 370, 70 mL']}, {'name': 'Isovue 370, 80 mL', 'type': 'DRUG', 'otherNames': ['Isovue'], 'description': '80 mL of iopamidol injection 370 injected at a rate of \\>=4 mL/second', 'armGroupLabels': ['Isovue 370, 80 mL']}, {'name': 'Isovue 370, 90 mL', 'type': 'DRUG', 'otherNames': ['Isovue'], 'description': '90 mL of iopamidol injection 370 injected at a rate of \\>=4 mL/second', 'armGroupLabels': ['Isovue 370, 90 mL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08540', 'city': 'Princeton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Bracco Diagnostics', 'geoPoint': {'lat': 40.34872, 'lon': -74.65905}}], 'overallOfficials': [{'name': 'Jiefen Yao, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bracco Diagnostics, Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bracco Diagnostics, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}