Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:56 AM
Study NCT ID:
NCT00783302
Status:
COMPLETED
Last Update Posted:
2014-12-11
First Post:
2008-10-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study in Subjects Suspected of Having CAD Undergoing VISIPAQUE-enhanced CCTA as Part of Their Routine Medical Care
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': 'paul.gordon@ge.com', 'phone': '011-47-2318-5822', 'title': 'Paul Gordon, PhD', 'organization': 'GE Healthcare'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'Adverse event collection were taken from 874 subjects coming from the safety population of this study.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm 1: Visipaque Injection x 320mgI/mL', 'description': 'Injection of Visipaque at a concentration of 320mg I /mL.', 'otherNumAtRisk': 874, 'otherNumAffected': 0, 'seriousNumAtRisk': 874, 'seriousNumAffected': 8}], 'seriousEvents': [{'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 874, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '11.0'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 874, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '11.0'}, {'term': 'Coronary Artery Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 874, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '11.0'}, {'term': 'Non-Cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 874, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '11.0'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 874, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '11.0'}, {'term': 'Aortic Aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 874, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '11.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Sensitivity of Visipaque-enhanced Coronary Computed Tomography Angiography (CCTA) for Predicting Downstream Cardiovascular Events at Each Follow-up Period When Compared to the Standard of Truth (SoT).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sensitivity - Subject Follow-up Period 1 Month', 'description': 'Number of Subjects Positive by Coronary Computed Tomography Angiography (CCTA) \\& Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).'}, {'id': 'OG001', 'title': 'Sensitivity - Subject Follow-up Period 6 Months', 'description': 'Number of Subjects Positive by Coronary Computed Tomography Angiography (CCTA) \\& Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).'}, {'id': 'OG002', 'title': 'Sensitivity - Subject Follow-up Period 12 Months', 'description': 'Number of Subjects Positive by Coronary Computed Tomography Angiography (CCTA) \\& Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).'}], 'classes': [{'categories': [{'measurements': [{'value': '96.1', 'groupId': 'OG000', 'lowerLimit': '86.5', 'upperLimit': '99.5'}, {'value': '95.8', 'groupId': 'OG001', 'lowerLimit': '88.1', 'upperLimit': '99.1'}, {'value': '94.7', 'groupId': 'OG002', 'lowerLimit': '87.1', 'upperLimit': '98.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 1 month, 6 months and 12 months post contrast administration.', 'description': 'Statistical analysis of the Sensitivity of Visipaque-enhanced CCTA for predicting downstream cardiovascular events at each follow-up period when compared to the SoT. The results are calculated as percentage of participants.', 'unitOfMeasure': 'Percentage of Subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The subject follow-up period went from 1 month, 6 months and 12 months.'}, {'type': 'PRIMARY', 'title': 'The Positive Predictive Value (PPV) of Visipaque-enhanced Coronary Computed Tomography Angiography (CCTA) for Ruling Out Downstream Cardiovascular Events at Each Follow-up Period When Compared to the Standard of Truth (SoT).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '172', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Positive Predictive Value - Subject Follow-up Period 1 Month', 'description': 'Number of Subjects True Positive by Coronary Computed Tomography Angiography (CCTA) / # Subjects Positive by Coronary Computed Tomography Angiography (CCTA)'}, {'id': 'OG001', 'title': 'Positive Predictive Value - Subject Follow-up Period 6 Months', 'description': 'Number of Subjects True Positive by Coronary Computed Tomography Angiography (CCTA) / # Subjects Positive by Coronary Computed Tomography Angiography (CCTA)'}, {'id': 'OG002', 'title': 'Positive Predictive Value - Subject Follow-up Period 12 Months', 'description': 'Number of Subjects True Positive by Coronary Computed Tomography Angiography (CCTA) / # Subjects Positive by Coronary Computed Tomography Angiography (CCTA)'}], 'classes': [{'categories': [{'measurements': [{'value': '28.2', 'groupId': 'OG000', 'lowerLimit': '21.6', 'upperLimit': '35.5'}, {'value': '39.3', 'groupId': 'OG001', 'lowerLimit': '32.0', 'upperLimit': '47.0'}, {'value': '41.9', 'groupId': 'OG002', 'lowerLimit': '34.4', 'upperLimit': '49.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 1 month, 6 months and 12 months post contrast administration.', 'description': 'Statistical analysis of the Positive Predictive Value (PPV) of Visipaque-enhanced CCTA for predicting downstream cardiovascular events at each follow-up period when compared to the SoT.The results are calculated as percentage of participants.', 'unitOfMeasure': 'Percentage of Subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'The Specificity of Visipaque-enhanced Coronary Computed Tomography Angiography (CCTA) for Ruling Out Downstream Cardiovascular Events at Each Follow-up Period When Compared to the Standard of Truth (SoT).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '806', 'groupId': 'OG000'}, {'value': '782', 'groupId': 'OG001'}, {'value': '767', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Specificity - Subject Follow-up Period 1 Month', 'description': 'Number of Subjects Negative by Coronary Computed Tomography Angiography (CCTA) \\& Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).'}, {'id': 'OG001', 'title': 'Specificity - Subject Follow-up Period 6 Months', 'description': 'Number of Subjects Negative by Coronary Computed Tomography Angiography (CCTA) \\& Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).'}, {'id': 'OG002', 'title': 'Specificity - Subject Follow-up Period 12 Months', 'description': 'Number of Subjects Negative by Coronary Computed Tomography Angiography (CCTA) \\& Standard of Truth (SoT) / # Subjects Negative by Standard of Truth (SoT).'}], 'classes': [{'categories': [{'measurements': [{'value': '84.5', 'groupId': 'OG000', 'lowerLimit': '81.8', 'upperLimit': '86.9'}, {'value': '86.6', 'groupId': 'OG001', 'lowerLimit': '84.0', 'upperLimit': '88.9'}, {'value': '87.0', 'groupId': 'OG002', 'lowerLimit': '84.4', 'upperLimit': '89.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 1 month, 6 months and 12 months post contrast administration.', 'description': 'Statistical analysis of the Specificity of Visipaque-enhanced CCTA for ruling out downstream cardiovascular events at each follow-up period when compared to the SoT.The results are calculated as percentage of participants.', 'unitOfMeasure': 'Percentage of Subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'The Negative Predictive Value (NPV) of Visipaque-enhanced Coronary Computed Tomography Angiography (CCTA) for Ruling Out Downstream Cardiovascular Events at Each Follow-up Period When Compared to the Standard of Truth (SoT).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '683', 'groupId': 'OG000'}, {'value': '680', 'groupId': 'OG001'}, {'value': '671', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Negative Predictive Value - Subject Follow-up Period 1 Month', 'description': 'Number of Subjects True Negative by Coronary Computed Tomography Angiography (CCTA) / # Subjects Negative by Coronary Computed Tomography Angiography (CCTA)'}, {'id': 'OG001', 'title': 'Negative Predictive Value - Subject Follow-up Period 6 Months', 'description': 'Number of Subjects True Negative by Coronary Computed Tomography Angiography (CCTA) / # Subjects Negative by Coronary Computed Tomography Angiography (CCTA)'}, {'id': 'OG002', 'title': 'Negative Predictive Value - Subject Follow-up Period 12 Months', 'description': 'Number of Subjects True Negative by Coronary Computed Tomography Angiography (CCTA) / # Subjects Negative by Coronary Computed Tomography Angiography (CCTA)'}], 'classes': [{'categories': [{'measurements': [{'value': '99.7', 'groupId': 'OG000', 'lowerLimit': '98.9', 'upperLimit': '100.0'}, {'value': '99.6', 'groupId': 'OG001', 'lowerLimit': '98.7', 'upperLimit': '99.9'}, {'value': '99.4', 'groupId': 'OG002', 'lowerLimit': '98.5', 'upperLimit': '99.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 1 month, 6 months and 12 months post contrast administration.', 'description': 'Statistical analysis of the Negative Predictive Value (NPV) of Visipaque-enhanced CCTA for ruling out downstream cardiovascular events at each follow-up period when compared to the SoT.The results are calculated as percentage of participants.', 'unitOfMeasure': 'Percentage of Subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Summary of Subjects Developing 1 or More Positive and Negative Cardiac Clinical Outcomes at 1 Month, 6 Months, and 12 Months After Undergoing Coronary Computed Tomography Angiography (CCTA) Examination Using Visipaque.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '857', 'groupId': 'OG000'}, {'value': '853', 'groupId': 'OG001'}, {'value': '843', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Follow-up Period at 1 Month', 'description': 'Summary of Patient-Level Clinical Outcomes by Follow-up Period (Efficacy Population) for 1 month.'}, {'id': 'OG001', 'title': 'Follow-up Period at 6 Months', 'description': 'Summary of Patient-Level Clinical Outcomes by Follow-up Period (Efficacy Population) for 6 months.'}, {'id': 'OG002', 'title': 'Follow-up Period at 12 Months', 'description': 'Summary of Patient-Level Clinical Outcomes by Follow-up Period (Efficacy Population) for 12 months.'}], 'classes': [{'title': 'Positive Clinical Outcome', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}]}, {'title': 'Negative Clinical Outcome', 'categories': [{'measurements': [{'value': '806', 'groupId': 'OG000'}, {'value': '782', 'groupId': 'OG001'}, {'value': '767', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 1 month, 6 months and 12 months post contrast administration.', 'description': 'The number of subjects in the efficacy population developing 1 or more positive and negative cardiac clinical outcomes at 1 month, 6 months, and 12 months after undergoing a Coronary Computed Tomography Angiography (CCTA) examination using Visipaque. Clinical outcomes are independent of any serious adverse events and adverse events associated with the drug administration.\n\nThis outcome measure is not reporting those subjects with serious adverse events and adverse events associated with the drug administration.', 'unitOfMeasure': 'Number of Subjects', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1: Visipaque Injection x 320mgI/mL', 'description': 'Injection of Visipaque at a concentration of 320mg I /mL.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '885'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '850'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'Technical Problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': '885 subjects enrolled in the Study. 874 subjects are in the safety population where adverse event data was collected, 857 subjects are in the efficacy population. 850 subjects completed the study. 35 subjects discontinued the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '874', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm 1: Visipaque Injection x 320mgI/mL', 'description': 'Injection of Visipaque at a concentration of 320mg I /mL.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.8', 'spread': '11.96', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '568', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '306', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '431', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '443', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '736', 'groupId': 'BG000'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '138', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 885}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-09', 'studyFirstSubmitDate': '2008-10-30', 'resultsFirstSubmitDate': '2014-11-04', 'studyFirstSubmitQcDate': '2008-10-30', 'lastUpdatePostDateStruct': {'date': '2014-12-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-12-09', 'studyFirstPostDateStruct': {'date': '2008-10-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Sensitivity of Visipaque-enhanced Coronary Computed Tomography Angiography (CCTA) for Predicting Downstream Cardiovascular Events at Each Follow-up Period When Compared to the Standard of Truth (SoT).', 'timeFrame': 'Within 1 month, 6 months and 12 months post contrast administration.', 'description': 'Statistical analysis of the Sensitivity of Visipaque-enhanced CCTA for predicting downstream cardiovascular events at each follow-up period when compared to the SoT. The results are calculated as percentage of participants.'}, {'measure': 'The Positive Predictive Value (PPV) of Visipaque-enhanced Coronary Computed Tomography Angiography (CCTA) for Ruling Out Downstream Cardiovascular Events at Each Follow-up Period When Compared to the Standard of Truth (SoT).', 'timeFrame': 'Within 1 month, 6 months and 12 months post contrast administration.', 'description': 'Statistical analysis of the Positive Predictive Value (PPV) of Visipaque-enhanced CCTA for predicting downstream cardiovascular events at each follow-up period when compared to the SoT.The results are calculated as percentage of participants.'}, {'measure': 'The Specificity of Visipaque-enhanced Coronary Computed Tomography Angiography (CCTA) for Ruling Out Downstream Cardiovascular Events at Each Follow-up Period When Compared to the Standard of Truth (SoT).', 'timeFrame': 'Within 1 month, 6 months and 12 months post contrast administration.', 'description': 'Statistical analysis of the Specificity of Visipaque-enhanced CCTA for ruling out downstream cardiovascular events at each follow-up period when compared to the SoT.The results are calculated as percentage of participants.'}, {'measure': 'The Negative Predictive Value (NPV) of Visipaque-enhanced Coronary Computed Tomography Angiography (CCTA) for Ruling Out Downstream Cardiovascular Events at Each Follow-up Period When Compared to the Standard of Truth (SoT).', 'timeFrame': 'Within 1 month, 6 months and 12 months post contrast administration.', 'description': 'Statistical analysis of the Negative Predictive Value (NPV) of Visipaque-enhanced CCTA for ruling out downstream cardiovascular events at each follow-up period when compared to the SoT.The results are calculated as percentage of participants.'}], 'secondaryOutcomes': [{'measure': 'Summary of Subjects Developing 1 or More Positive and Negative Cardiac Clinical Outcomes at 1 Month, 6 Months, and 12 Months After Undergoing Coronary Computed Tomography Angiography (CCTA) Examination Using Visipaque.', 'timeFrame': 'Within 1 month, 6 months and 12 months post contrast administration.', 'description': 'The number of subjects in the efficacy population developing 1 or more positive and negative cardiac clinical outcomes at 1 month, 6 months, and 12 months after undergoing a Coronary Computed Tomography Angiography (CCTA) examination using Visipaque. Clinical outcomes are independent of any serious adverse events and adverse events associated with the drug administration.\n\nThis outcome measure is not reporting those subjects with serious adverse events and adverse events associated with the drug administration.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CAD', 'Visipaque', 'CCTA'], 'conditions': ['Coronary Artery Disease (CAD)']}, 'descriptionModule': {'briefSummary': 'To assess prognostic value of CCTA examination in subjects who undergo CCTA as part of their medical care when compared to a standard of truth, i.e. subject outcomes during each follow-up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient suspected of having coronary artery disease or CAD.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The subject is over 18 years old, exhibits chest pain syndrome and is scheduled to undergo a VISIPAQUE-enhanced CCTA examination for one of the following reasons:- Intermediate pre-test probability of CAD.\n* An uninterruptible/equivocal stress test (exercise, perfusion, or stress echo).'}, 'identificationModule': {'nctId': 'NCT00783302', 'briefTitle': 'Study in Subjects Suspected of Having CAD Undergoing VISIPAQUE-enhanced CCTA as Part of Their Routine Medical Care', 'organization': {'class': 'INDUSTRY', 'fullName': 'GE Healthcare'}, 'officialTitle': 'A Prospective, Multi-Center Registry Study for Clinical Outcome in Subjects Undergoing Coronary Computed Tomography Angiography (CCTA) Examination (VISIPAQUE Registry Study)', 'orgStudyIdInfo': {'id': 'GE-012-096'}}, 'contactsLocationsModule': {'locations': [{'zip': '08540', 'city': 'Princeton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'GE Healthcare', 'geoPoint': {'lat': 40.34872, 'lon': -74.65905}}], 'overallOfficials': [{'name': 'Rubin Sheng, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'GE Healthcare'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GE Healthcare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}