Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-01-03 @ 9:23 AM
Study NCT ID:
NCT00622167
Status:
TERMINATED
Last Update Posted:
2012-02-03
First Post:
2008-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of DSCT With IB-IVUS and Angiography in the Assessment of Coronary Artery Disease
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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'imcnulty@partners.org', 'phone': '617 726 2612', 'title': 'Iris McNulty, RN', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Study terminated after imaging 4 subjects due to slow enrollment. Results will not be analyzed.'}}, 'adverseEventsModule': {'description': 'Total number of subjects at risk=4 since 20 subjects were screen failures and did not have any study imaging.', 'eventGroups': [{'id': 'EG000', 'title': 'IBIVUS and DSCT', 'description': 'All patients will receive integrated backscatter IVUS and dual source CT.', 'otherNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Comparison of Plaque Characteristics Between DSCT (Dual Source Computed Tomography) and IVUS (Intravascular Ultrasound).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}, {'units': 'Plaques', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Plaque Characteristics', 'description': 'Characteristics include plaque cross-sectional diameter, area measurements, plaque volume, and plaque morphology.'}], 'analyses': [{'pValue': '0', 'groupIds': ['OG000'], 'ciPctValue': '0', 'groupDescription': 'Plaque characteristics including plaque cross-sectional diameter, area measurements, plaque volume, and plaque morphology would be compared between IBIVUS, DSCT and angiography.', 'statisticalMethod': 'Not done', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'At time of imaging', 'description': 'Characteristics include plaque cross-sectional diameter, area measurements, plaque volume, and plaque morphology (composition).', 'unitOfMeasure': 'plaques', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Plaques', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Imaging 30 subjects was predicted to include enough plaques for analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IBIVUS and DSCT', 'description': 'All patients will receive integrated backscatter IVUS and dual source CT.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}], 'dropWithdraws': [{'type': 'Did not meet angiographic criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}]}]}], 'recruitmentDetails': 'Subjects were enrolled from January 2008 until September 2008. The study ended early due to slow enrollment.', 'preAssignmentDetails': 'Subjects were consented prior to cardiac catheterization, and if they did not meet angiographic inclusion criteria they were withdrawn from the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'IBIVUS and DSCT', 'description': 'All patients will receive integrated backscatter IVUS and dual source CT.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Study terminated after imaging 4 subjects due to slow enrollment. No analysis performed.', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'whyStopped': 'Subject recruitment was slow, so enrollment has been closed.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-03', 'studyFirstSubmitDate': '2008-02-12', 'resultsFirstSubmitDate': '2011-07-28', 'studyFirstSubmitQcDate': '2008-02-21', 'lastUpdatePostDateStruct': {'date': '2012-02-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-01-03', 'studyFirstPostDateStruct': {'date': '2008-02-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of Plaque Characteristics Between DSCT (Dual Source Computed Tomography) and IVUS (Intravascular Ultrasound).', 'timeFrame': 'At time of imaging', 'description': 'Characteristics include plaque cross-sectional diameter, area measurements, plaque volume, and plaque morphology (composition).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Plaque characteristics', 'DSCT', 'IVUS'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare different methods of looking at atherosclerotic plaques in heart arteries. Identifying the characteristics of these plaques noninvasively would be very valuable. This study is looking at a new CT scanner (DSCT) to noninvasively image these plaques compared to invasive ultrasound (the current standard).', 'detailedDescription': 'The primary objectives of this study are:\n\n1. To compare with contrast angiography, the ability of DSCT to detect and quantify coronary artery stenoses.\n2. To compare with gray-scale IVUS, the ability of DSCT to quantify plaque cross-sectional diameter \\& area measurements \\& plaque volume.\n3. To evaluate the ability of DSCT to assess plaque morphology and quantify plaque components as compared to gray-scale and IB-IVUS.\n4. To evaluate the ability of DSCT to identify \\& measure lesion remodeling compared to gray-scale IVUS.\n5. To determine if pre-PCI evaluation of coronary plaque morphology by IB-IVUS can a) predict procedural success as assessed by adequate stent strut apposition and expansion and b) peri-procedural myocardial necrosis as measured by biomarker elevation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or non-pregnant females\n* \\> / = 18 years of age\n* Scheduled for coronary angiography\n\nExclusion Criteria:\n\n* Acute ST-elevation myocardial infarction within last 72 hours\n* Current congestive heart failure\n* Current cardiogenic shock\n* Unstable clinical condition\n* Known cardiomyopathy (EF \\< 30%)\n* Creatinine \\>1.5 mg/dL\n* Definite allergy to iodinated contrast media\n* Current participation in an investigational drug or device research study\n* HR \\> 65 and contraindications to the administration of beta blockers\n\nExclusion criteria assessed during catheterization procedure\n\n* PCI of native coronary vessel not performed\n* Left main stenosis \\> 50%\n* Any vessel contraindicated for IVUS imaging\n* Any lesion contraindicated for IVUS imaging\n* Inability to pass IVUS catheter\n* PCI of bifurcation lesion'}, 'identificationModule': {'nctId': 'NCT00622167', 'briefTitle': 'Comparison of DSCT With IB-IVUS and Angiography in the Assessment of Coronary Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Comparison of Dual Source Computed Tomography (DSCT) With Integrated Backscatter Intravascular Ultrasound (IB-IVUS) and Contrast Angiography in the Assessment of Coronary Artery Disease', 'orgStudyIdInfo': {'id': '2007P001842'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': 'All patients will receive integrated backscatter IVUS and dual source CT.', 'interventionNames': ['Device: Integrated Backscatter IVUS', 'Device: Dual Source Computed Tomography']}], 'interventions': [{'name': 'Integrated Backscatter IVUS', 'type': 'DEVICE', 'description': 'All subjects have Integrated Backscatter IVUS and Dual Source CT imaging.', 'armGroupLabels': ['1']}, {'name': 'Dual Source Computed Tomography', 'type': 'DEVICE', 'description': 'All subjects have DSCT and IBIVUS imaging', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Ik-Kyung Jang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Ik-Kyung Jang, MD, PhD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}