Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2025-12-31 @ 8:25 AM
Study NCT ID:
NCT01694368
Status:
COMPLETED
Last Update Posted:
2025-08-07
First Post:
2012-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intracoronary Imaging With NIRS-IVUS to Characterize Arterial Plaques
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2021-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-01', 'studyFirstSubmitDate': '2012-09-24', 'studyFirstSubmitQcDate': '2012-09-24', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-09-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MACCE', 'timeFrame': '5 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Near infrared spectroscopy; lipid core; vulnerable plaque'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '26729855', 'type': 'DERIVED', 'citation': 'Madder RD, Khan M, Husaini M, Chi M, Dionne S, VanOosterhout S, Borgman A, Collins JS, Jacoby M. Combined Near-Infrared Spectroscopy and Intravascular Ultrasound Imaging of Pre-Existing Coronary Artery Stents: Can Near-Infrared Spectroscopy Reliably Detect Neoatherosclerosis? Circ Cardiovasc Imaging. 2016 Jan;9(1):e003576. doi: 10.1161/CIRCIMAGING.115.003576.'}]}, 'descriptionModule': {'briefSummary': 'To characterize atherosclerotic coronary artery plaques using advanced intra-coronary imaging with a combined near-infrared spectroscopy and intravascular ultrasound catheter before and after percutaneous intervention', 'detailedDescription': 'This study is being performed to characterize the composition and morphologic characteristics of atherosclerotic coronary artery plaques with intra-coronary near-infrared spectroscopy and intravascular ultrasound in patients undergoing percutaneous coronary intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Coronary Artery Disease Patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject is at \\> 18 years of age\n2. Subject presents to the catheterization laboratory to undergo clinically-indicated, invasive coronary angiography\n3. Subject is willing and able to provide informed written consent\n4. Subject is found to have ≥ 1 severe coronary artery stenosis by invasive angiography and percutaneous coronary intervention is planned for definitive treatment or found to have ≥ 1 intermediate coronary artery stenosis and IVUS planned for lesion assessment\n5. Coronary anatomy is deemed suitable for combined NIRS-IVUS by the interventional cardiologist performing invasive angiography and intervention\n\nExclusion Criteria:\n\n1. Subject is pregnant or suspected to be pregnant\n2. Subject is unable to provide informed consent\n3. Subject has coronary artery anatomy deemed by interventionalist as unsuitable for NIRS-IVUS'}, 'identificationModule': {'nctId': 'NCT01694368', 'acronym': 'NIRS-IVUS', 'briefTitle': 'Intracoronary Imaging With NIRS-IVUS to Characterize Arterial Plaques', 'organization': {'class': 'OTHER', 'fullName': 'Corewell Health West'}, 'officialTitle': 'Multimodality Advanced Intracoronary Imaging With Near-infrared Spectroscopy and Intravascular Ultrasound to Characterize Coronary Artery Plaques Before and After Percutaneous Intervention', 'orgStudyIdInfo': {'id': '2011-285'}}, 'contactsLocationsModule': {'locations': [{'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Spectrum Health; Frederik Meijer Heart &Vascular Institute', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}], 'overallOfficials': [{'name': 'Ryan D Madder, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Corewell Health West'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corewell Health West', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician', 'investigatorFullName': 'Ryan Madder, MD', 'investigatorAffiliation': 'Corewell Health West'}}}}