Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-02-25 @ 9:50 PM
Study NCT ID:
NCT01506960
Status:
TERMINATED
Last Update Posted:
2013-11-18
First Post:
2012-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of a Combined Near Infrared Spectroscopy (NIRS) and Intravascular Ultrasound (IVUS) Catheter for Detection of Lipid Rich Plaque
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', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Subjects Having NIRS/IVUS and OCT Imaging During PCI.', 'otherNumAtRisk': 17, 'otherNumAffected': 5, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Back pain post procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Non-ischemic chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Post-procedural myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'PVCs during NIRS IVUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Detection of Lipid Rich Plaque by Near Infrared Spectroscopy (NIRS) Intravascular Ultrasound (IVUS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Having NIRS/IVUS and OCT Imaging During PCI.'}], 'classes': [{'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured one point in time during cardiac catheterization', 'description': 'Subjects are presenting for their clinically-indicated cardiac catheterization. NIRS/IVUS imaging will be done at the time of catheterization.', 'unitOfMeasure': '% pts with lipid on NIRS and OCT', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Differences in NIRS Parameters Between Deep and Superficial Lipid Assessed by Optical Coherence Tomography (OCT).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'units': 'Lesions', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Superficial Lipid'}, {'id': 'OG001', 'title': 'Deep Lipid'}], 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '3.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at the time of cardiac catheterization', 'description': 'Subjects are presenting for their clinically-indicated cardiac catheterization. NIRS/IVUS imaging will be done at the time of catheterization. Plaques were divided depending on depth of lipid by OCT (cut off value 130 um).', 'unitOfMeasure': 'mm (LCP length)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Per protocol'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Coronary Stenting With OCT, NIRS/IVUS', 'description': 'All subjects will have Near Infrared Spectroscopy/Intravascular Ultrasound Imaging performed.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}]}], 'dropWithdraws': [{'type': 'Did not meet angiographic criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '47'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Subjects Having NIRS/IVUS and OCT Imaging During PCI.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.8', 'spread': '8.5', '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': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '47 subjects did not meet angiographic criteria for participation.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'whyStopped': 'It was felt that a sufficient number of subjects were enrolled.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-23', 'studyFirstSubmitDate': '2012-01-03', 'resultsFirstSubmitDate': '2013-05-16', 'studyFirstSubmitQcDate': '2012-01-09', 'lastUpdatePostDateStruct': {'date': '2013-11-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-08-08', 'studyFirstPostDateStruct': {'date': '2012-01-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection of Lipid Rich Plaque by Near Infrared Spectroscopy (NIRS) Intravascular Ultrasound (IVUS)', 'timeFrame': 'Measured one point in time during cardiac catheterization', 'description': 'Subjects are presenting for their clinically-indicated cardiac catheterization. NIRS/IVUS imaging will be done at the time of catheterization.'}], 'secondaryOutcomes': [{'measure': 'Differences in NIRS Parameters Between Deep and Superficial Lipid Assessed by Optical Coherence Tomography (OCT).', 'timeFrame': 'Measured at the time of cardiac catheterization', 'description': 'Subjects are presenting for their clinically-indicated cardiac catheterization. NIRS/IVUS imaging will be done at the time of catheterization. Plaques were divided depending on depth of lipid by OCT (cut off value 130 um).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn more about lipid rich plaque using Near Infrared Spectroscopy (NIRS)/Intravascular Ultrasound (IVUS) imaging in patients who have had coronary artery stenting and Optical coherence tomography (OCT) imaging.', 'detailedDescription': 'The aims of this study are to:\n\n1. Test the ability of the new NIRS IVUS system to detect lipid pool\n2. Evaluate the accuracy of the NIRS IVUS system for localization of lipide rich plaque: superficial vs deep\n3. Improve diagnostic accuracy of OCT for detection of lipid using information from NIRS IVUS'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatient Characteristics\n\n1. Males and non-pregnant females \\> 18 and \\< 79 years of age\n2. Patients referred for diagnostic coronary angiography who are found to have lesions in native coronary arteries which will be treated by percutaneous coronary intervention (PCI) (or patients with known coronary lesions who are referred for planned PCI)\n3. Able to give written informed consent\n\nLesion Characteristics\n\n1. Lesion in native coronary artery\n2. Angiographic stenosis \\> 50%\n3. Reference vessel diameter 2.5 mm - 4.0 mm by visual estimation\n4. Subjects who have successful PCI and OCT\n\nGeneral Exclusion Criteria\n\n1. Subjects who are unable or unwilling to sign the informed consent form\n2. Subjects with serious co-morbid conditions that in judgment of the investigator preclude inclusion in this study (such as terminal cancer, life expectancy \\< 6 months, Liver Function Tests (LFTs) \\> 3 times Upper Limit of Normal (ULN), or post-transplant)\n3. Subjects with New York Heart Association (NYHA) class III or IV heart failure or known left ventricular ejection fraction \\< 30%\n4. Subjects who have experienced an ST-elevation myocardial infarction (STEMI) within 72 hours prior to the procedure\n5. Subjects with hemodynamic or electrical instability (including shock)\n6. Subjects diagnosed with severe, non-catheter-related coronary artery spasm\n7. Subjects who are or may be pregnant\n8. Subjects with known allergies to contrast media\n9. Subjects with renal failure as defined by estimated Glomerular Filtration Rate (eGFR) \\< 60.\n10. History of Transient Ischemic Attack (TIA) or stroke \\< 6 months\n\nLesion Specific Exclusion Criteria These exclusion criteria apply to the target lesion to be imaged by NIRS IVUS.\n\n1. Lesion located in the left main coronary artery\n2. Lesions that are heavily calcified\n3. Lesions where OCT cannot be performed due to technical difficulties\n4. Other lesions that the investigator deems inappropriate for the procedure such as lesions with excessive tortuosity, presence of thrombus, low flow by TIMI grade.'}, 'identificationModule': {'nctId': 'NCT01506960', 'briefTitle': 'Evaluation of a Combined Near Infrared Spectroscopy (NIRS) and Intravascular Ultrasound (IVUS) Catheter for Detection of Lipid Rich Plaque', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Evaluation of a Combined Near Infrared Spectroscopy (NIRS) and Intravascular Ultrasound (IVUS) Catheter for Detection of Lipid Rich Plaque', 'orgStudyIdInfo': {'id': '2010P001608'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Coronary stenting with OCT, NIRS/IVUS', 'description': 'All subjects will have Near Infrared Spectroscopy/Intravascular Ultrasound Imaging performed.', 'interventionNames': ['Device: InfraReDx Lipiscan IVUS']}], 'interventions': [{'name': 'InfraReDx Lipiscan IVUS', 'type': 'DEVICE', 'description': 'Near Infrared Spectroscopy/Intravascular Ultrasound will be performed following OCT imaging.', 'armGroupLabels': ['Coronary stenting with OCT, NIRS/IVUS']}]}, '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'}, 'collaborators': [{'name': 'Infraredx', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Ik-Kyung Jang, MD, PhD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}