Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-03-03 @ 6:46 PM
Study NCT ID:
NCT02033694
Status:
COMPLETED
Last Update Posted:
2020-05-19
First Post:
2014-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Lipid-Rich Plaque Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D058225', 'term': 'Plaque, Amyloid'}], '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'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pshah@infraredx.com', 'phone': '781-345-9646', 'title': 'Priti Shah', 'phoneExt': '646', 'organization': 'Infraredx, A Nipro Company'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '2 years', 'description': 'The device has been approved as safe for imaging of coronary arteries by the FDA. Experience in greater than 5,000 patients has shown that the device safety profile does not differ from that of a conventional IVUS catheter. Serious adverse events associated with the device in the additional, non-culprit vessels were collected because this was the additional requirement for the study outside of routine medical care.', 'eventGroups': [{'id': 'EG000', 'title': 'All Patients With Baseline NIRS-IVUS Imaging', 'description': 'Participants with NIRS-IVUS imaging at baseline', 'otherNumAtRisk': 1563, 'deathsNumAtRisk': 1563, 'otherNumAffected': 0, 'seriousNumAtRisk': 1563, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'seriousEvents': [{'term': 'Dissection', 'notes': 'Intraprocedural complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1563, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bradycardia', 'notes': 'Intraprocedural complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1563, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombus with Chest Pain', 'notes': 'Intraprocedural complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1563, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Stratified as Non-Index Culprit Lesion Related Major Adverse Cardiac Events (NC-MACE) or No NC-MACE and Association With maxLCBI4mm as a Continuous Variable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1271', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With 2 Year Follow up', 'description': 'Participants with NIRS-IVUS imaging at baseline and assigned to follow up for Non-Index Culprit Lesion related Major Adverse Cardiac Events (NC-MACE) for 2 years'}], 'classes': [{'title': 'Participants with NC-MACE', 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}]}]}, {'title': 'Participants with No NC-MACE', 'categories': [{'measurements': [{'value': '1167', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0004', 'groupIds': ['OG000'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.21', 'ciLowerLimit': '1.09', 'ciUpperLimit': '1.35', 'groupDescription': 'Hypothesis 1 (Vulnerable Patient Hypothesis) first fit a univariate proportional hazards regression model in which maxLCBI4mm is the only independent variable and NC-MACE during 2 years is the outcome. The null hypothesis tested by the Wald test that the regression coefficient in a proportional hazards regression model is significantly different from 0. This analysis determined whether maxLCBI4mmI is a risk factor for NC-MACE.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.45', 'ciLowerLimit': '1.30', 'ciUpperLimit': '1.60', 'groupDescription': 'Hypothesis 2 (Vulnerable Plaque Hypothesis) first fit a univariate proportional hazards regression model in which maxLCBI4mm in the coronary artery segment is the measure of exposure and NC-MACE during 2 years caused by a new culprit lesion in that segment is the outcome. This analysis was performed with adjustment for the potential clustering effect within patient utilizing the Wei, Lin and Weissfeld (WLW) methodology. This analysis determined whether maxLCBI4mm is a risk factor NC-MACE.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years', 'description': 'Association of maximum 4 mm Lipid Core Burden Index (maxLCBI4mm) as a continuous value in 100 unit increments in all imaged arteries and NC-MACE at both (1) Patient Level and (2) Plaque Level\n\nNon-Index Culprit Lesion related Major Adverse Cardiac Events (NC-MACE) is defined as a composite of:\n\n* cardiac death\n* cardiac arrest\n* non-fatal myocardial infarction (MI)\n* acute coronary syndrome\n* revascularization by coronary artery bypass graft (CABG) or percutaneous intervention (PCI)\n* rehospitalization for progressive angina, related to a non-index culprit lesion', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients assigned to 2 year follow up were analyzed, at the patient and plaque level, to test the association between maximum 4 mm Lipid Core Burden Index (maxLCBI4mm) and Non-Index Culprit Lesion related Major Adverse Cardiac Events (NC-MACE).'}, {'type': 'SECONDARY', 'title': 'Number of Participants Stratified as NC-MACE or No NC-MACE and Association With maxLCBI4mm More Than a Threshold of 400', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1271', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With 2 Year Follow up', 'description': 'Participants with NIRS-IVUS imaging at baseline and follow up for 2 years'}], 'classes': [{'title': 'Participants with NC-MACE', 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}]}]}, {'title': 'Participants with No NC-MACE', 'categories': [{'measurements': [{'value': '1167', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.18', 'ciLowerLimit': '1.48', 'ciUpperLimit': '3.22', 'groupDescription': 'Secondary Hypothesis 1 (Vulnerable Patient)- Cox proportional hazards regression model to assess a threshold of maxLCBI4mm \\> 400 as the independent variable and NC-MACE during 2 years as the outcome.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.22', 'ciLowerLimit': '2.39', 'ciUpperLimit': '7.45', 'groupDescription': 'Secondary Hypothesis 2 (Vulnerable Plaque)- Cox proportional hazards regression model to assess a threshold of maxLCBI4mm \\> 400 in the coronary artery segment as the independent variable and NC-MACE during 2 years caused by a new culprit lesion in that segment is the outcome.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years', 'description': 'Association of maxLCBI4mm more than and less than a threshold of 400 in all imaged arteries and NC-MACE at both (1) Patient Level and (2) Plaque Level\n\nNon-Index Culprit Lesion related Major Adverse Cardiac Events (NC-MACE) is defined as a composite of:\n\n* cardiac death\n* cardiac arrest\n* non-fatal myocardial infarction (MI)\n* acute coronary syndrome\n* revascularization by coronary artery bypass graft (CABG) or percutaneous intervention (PCI)\n* rehospitalization for progressive angina, related to a non-index culprit lesion', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients assigned to 2 year follow up were analyzed, at the patient and plaque level to test the association between maximum 4mm Lipid Core Burden index (maxLCBI4mm) \\>400 and Non-Index Culprit Lesion related Major Cardiac Events (NC-MACE)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Participants With 2 Year Follow up', 'description': 'Participants with NIRS-IVUS imaging at baseline and assigned to follow up for Non-Index Culprit Lesion related Major Adverse Cardiac Events (NC-MACE) for 2 years'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1271'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1271'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Enrolled patients with a large LRP (Maximum Lipid Core Burden Index\\>250 in 4 mm or maxLCBI4mm\\>=250) were assigned to 2 year follow up to determine if a new coronary event had occurred. A randomly selected half of the patients with a small or no LRP (MaxLCBI4mm\\<250) had 2 year follow up.', 'preAssignmentDetails': 'A randomly selected half of the patients with a small or no LRP (MaxLCBI4mm\\<250) did not have 2 year follow up and were not included in the primary analyses. This reduced the total number of patients followed for two years to 1271 patients.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1271', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Participants With 2 Year Follow up', 'description': 'Participants with NIRS-IVUS imaging at baseline and assigned to follow up for Non-Index Culprit Lesion related Major Adverse Cardiac Events (NC-MACE) for 2 years'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64', 'spread': '10.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '388', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '883', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '942', 'groupId': 'BG000'}]}]}, {'title': 'African American', 'categories': [{'measurements': [{'value': '158', 'groupId': 'BG000'}]}]}, {'title': 'Asian Pacific', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}]}]}, {'title': 'Native American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '128', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '101', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participant could identify as more than one race/ethnicity and may be counted in more than one race/ethnicity category', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Netherlands', 'categories': [{'measurements': [{'value': '187', 'groupId': 'BG000'}]}]}, {'title': 'Latvia', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '1001', 'groupId': 'BG000'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'Slovakia', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-12-26', 'size': 435811, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-04-13T10:31', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1563}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-06', 'studyFirstSubmitDate': '2014-01-08', 'resultsFirstSubmitDate': '2020-04-13', 'studyFirstSubmitQcDate': '2014-01-09', 'lastUpdatePostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-06', 'studyFirstPostDateStruct': {'date': '2014-01-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Stratified as Non-Index Culprit Lesion Related Major Adverse Cardiac Events (NC-MACE) or No NC-MACE and Association With maxLCBI4mm as a Continuous Variable', 'timeFrame': '2 years', 'description': 'Association of maximum 4 mm Lipid Core Burden Index (maxLCBI4mm) as a continuous value in 100 unit increments in all imaged arteries and NC-MACE at both (1) Patient Level and (2) Plaque Level\n\nNon-Index Culprit Lesion related Major Adverse Cardiac Events (NC-MACE) is defined as a composite of:\n\n* cardiac death\n* cardiac arrest\n* non-fatal myocardial infarction (MI)\n* acute coronary syndrome\n* revascularization by coronary artery bypass graft (CABG) or percutaneous intervention (PCI)\n* rehospitalization for progressive angina, related to a non-index culprit lesion'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Stratified as NC-MACE or No NC-MACE and Association With maxLCBI4mm More Than a Threshold of 400', 'timeFrame': '2 years', 'description': 'Association of maxLCBI4mm more than and less than a threshold of 400 in all imaged arteries and NC-MACE at both (1) Patient Level and (2) Plaque Level\n\nNon-Index Culprit Lesion related Major Adverse Cardiac Events (NC-MACE) is defined as a composite of:\n\n* cardiac death\n* cardiac arrest\n* non-fatal myocardial infarction (MI)\n* acute coronary syndrome\n* revascularization by coronary artery bypass graft (CABG) or percutaneous intervention (PCI)\n* rehospitalization for progressive angina, related to a non-index culprit lesion'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Lipid', 'Vulnerable Plaque', 'Plaque', 'Cholesterol', 'Near Infrared Spectroscopy', 'NIRS-IVUS', 'Intravascular Ultrasound', 'Angiography', 'Coronary Imaging'], 'conditions': ['Coronary Artery Disease', 'Atherosclerosis']}, 'referencesModule': {'references': [{'pmid': '28938968', 'type': 'BACKGROUND', 'citation': 'Waksman R, Torguson R, Spad MA, Garcia-Garcia H, Ware J, Wang R, Madden S, Shah P, Muller J. The Lipid-Rich Plaque Study of vulnerable plaques and vulnerable patients: Study design and rationale. Am Heart J. 2017 Oct;192:98-104. doi: 10.1016/j.ahj.2017.02.010. Epub 2017 Feb 16.'}, {'pmid': '31570255', 'type': 'BACKGROUND', 'citation': 'Waksman R, Di Mario C, Torguson R, Ali ZA, Singh V, Skinner WH, Artis AK, Cate TT, Powers E, Kim C, Regar E, Wong SC, Lewis S, Wykrzykowska J, Dube S, Kazziha S, van der Ent M, Shah P, Craig PE, Zou Q, Kolm P, Brewer HB, Garcia-Garcia HM; LRP Investigators. Identification of patients and plaques vulnerable to future coronary events with near-infrared spectroscopy intravascular ultrasound imaging: a prospective, cohort study. Lancet. 2019 Nov 2;394(10209):1629-1637. doi: 10.1016/S0140-6736(19)31794-5. Epub 2019 Sep 27.'}, {'pmid': '37271594', 'type': 'DERIVED', 'citation': 'Torguson R, Mintz GS, Di Mario C, Ten Cate T, Ali ZA, Singh V, Skinner W, Zhang C, Shea C, Kuku KO, Garcia-Garcia HM, Waksman R. Disparities among Black and White patients in plaque burden and composition and long-term impact. Cardiovasc Revasc Med. 2023 Oct;55:28-32. doi: 10.1016/j.carrev.2023.04.023. Epub 2023 May 1.'}, {'pmid': '36058829', 'type': 'DERIVED', 'citation': 'Case BC, Torguson R, Mintz GS, Di Mario C, Medranda GA, Zhang C, Shea C, Garcia-Garcia HM, Waksman R. Additive Effect of Multiple High-Risk Coronary Artery Segments on Patient Outcomes: LRP Study Sub-Analysis. Cardiovasc Revasc Med. 2023 Jan;46:38-43. doi: 10.1016/j.carrev.2022.08.008. Epub 2022 Aug 6.'}, {'pmid': '35842005', 'type': 'DERIVED', 'citation': 'Torguson R, Mintz GS, Case BC, Di Mario C, Zhang C, Shea C, Garcia-Garcia HM, Waksman R. Correlation between lipidic content and arterial-wall plaque burden: A Lipid Rich Plaque study sub-analysis. Int J Cardiol. 2022 Nov 1;366:32-34. doi: 10.1016/j.ijcard.2022.07.024. Epub 2022 Jul 13.'}, {'pmid': '34972665', 'type': 'DERIVED', 'citation': 'Case BC, Shea C, Torguson R, Zhang C, Yerasi C, Medranda GA, Kuku KO, Garcia-Garcia HM, Mintz GS, Waksman R. Impact of Baseline Imaging of Non-Culprit Coronary Lesions on Adverse Events: Insight From LRP Study. Cardiovasc Revasc Med. 2022 Jun;39:1-5. doi: 10.1016/j.carrev.2021.12.012. Epub 2021 Dec 13.'}, {'pmid': '34465457', 'type': 'DERIVED', 'citation': 'Torguson R, Shlofmitz E, Mintz GS, Mario CD, Cate TT, Ali ZA, Singh V, Skinner W, Zhang C, Shea C, Garcia-Garcia HM, Waksman R. Frequency of Lipid-Rich Coronary Plaques in Stable Angina Pectoris versus Acute Coronary Syndrome (from the Lipid Rich Plaque Study). Am J Cardiol. 2021 Nov 1;158:1-5. doi: 10.1016/j.amjcard.2021.07.033. Epub 2021 Aug 28.'}, {'pmid': '34455112', 'type': 'DERIVED', 'citation': 'Bambagioni G, Di Mario C, Torguson R, Demola P, Ali Z, Singh V, Skinner W, Artis A, Cate TT, Zhang C, Garcia-Garcia HM, Doros G, Mintz GS, Waksman R. Lipid-rich plaques detected by near-infrared spectroscopy predict coronary events irrespective of age: A Lipid Rich Plaque sub-study. Atherosclerosis. 2021 Oct;334:17-22. doi: 10.1016/j.atherosclerosis.2021.08.022. Epub 2021 Aug 14.'}], 'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pubmed/28938968', 'label': 'The Lipid-Rich Plaque Study of vulnerable plaques and vulnerable patients: Study design and rationale. Am Heart J. 2017'}, {'url': 'https://www.ncbi.nlm.nih.gov/pubmed/31570255', 'label': 'Identification of patients and plaques vulnerable to future coronary events with near-infrared spectroscopy intravascular ultrasound imaging: a prospective, cohort study. Lancet. 2019'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to enhance medical knowledge of the causes of future coronary problems. Many studies in patients who have already experienced a coronary problem point to the danger associated with plaques that are rich in cholesterol. This study determines if the near-infrared method of detection of these fatty plaques can predict future events. If dangerous plaques can be identified, there are many treatments already available that could be tested for their ability to prevent coronary events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presenting for coronary angiography in whom IVUS and/or NIRS evaluation is planned or could be utilized as part of their clinically-indicated evaluation will be screened for participation.\n\nAll enrolled patients with a large LRP (Maximum Lipid Core Burden Index\\>250 in 4 mm or maxLCBI4mm\\>=250) was contacted by phone for each clinical follow up visit to determine if a new coronary event had occurred. A randomly selected half of the patients with a small, or no LRP (MaxLCBI4mm\\<250) received an identical follow-up. The remaining half of the small or no LRP group did not have follow up visits and therefore were not included in the primary analysis. The determination of the need for follow-up was made by a core lab and communicated to the clinical site.', 'healthyVolunteers': False, 'eligibilityCriteria': 'General Inclusion Criteria:\n\n* Subjects presenting for coronary angiography in whom IVUS imaging is likely to be performed for clinical purposes.\n* Greater than 18 years of age.\n* Clinical presenting symptoms meeting one of the three criteria below:\n\n 1. Subjects presenting with an acute coronary syndrome (ACS) including at least one of the following:\n\n 1. Elevated cardiac biomarkers with CK-MB or troponin greater than upper limits of normal;\n 2. ST depression or ST elevation \\>1mm in 2 or more contiguous leads in the absence of LVH, paced rhythm, BBB or early repolarization;\n 3. A stabilized patient 24 to 72 hours post STEMI;\n 2. Unstable angina pectoris;\n 3. Stable angina pectoris and/or a positive functional study with evidence of ischemia.\n\nAngiographic Inclusion Criteria\n\n* At least one Suspected Index Culprit Lesion requiring imaging with IVUS and/or NIRS for clinical indications.\n* At least two native epicardial coronary arteries (which may include the Suspected Index Culprit Artery) eligible for imaging with NIRS-IVUS.\n\nIVUS/NIRS Imaging Inclusion Criterion\n\n* A minimum of a total 50 mm of coronary artery not involved in a prior or Index Procedure PCI (including the 5mm borders on either edge of the site receiving PCI) must be scanned. This 50mm total length may include contributions from the Suspected Index Culprit Arteries and from Index Non-Culprit Arteries. This total length must include contributions from two or more native imaged arteries.\n\nExclusion Criteria:\n\n* Unstable patients (STEMI within the prior 24 hours; cardiogenic shock, hypotension needing inotropes, hypoxia needing intubation, and IABP) and patients that had a procedural complication (coronary dissection, perforation or a complication that would necessitate immediate-unplanned revascularization) during index PCI procedure.\n* History of CABG or planned CABG within 6 months following NIRS-IVUS imaging.\n* Patient has additional lesion(s) that needs a staged PCI.\n* Subject life expectancy is less than 2 years at time of index catheterization.\n* Subject with ejection fraction (EF) \\<30%.\n* Subject pacemaker dependent/paced rhythm.\n* Subject pregnant and lactating.\n* Any other factor that the investigator feels would put the patient at increased risk or otherwise make the patient unsuitable for participation in the protocol\n* Patients undergoing performance of PCI in all three major vessels during the index PCI.'}, 'identificationModule': {'nctId': 'NCT02033694', 'acronym': 'LRP', 'briefTitle': 'The Lipid-Rich Plaque Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Infraredx'}, 'officialTitle': 'The Lipid-Rich Plaque (LRP) Study', 'orgStudyIdInfo': {'id': 'The LRP Study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants With 2 Years Follow up', 'description': 'Participants with NIRS-IVUS imaging at baseline and assigned to follow up for Non-Index Culprit Lesion related Major Adverse Cardiac Events (NC-MACE) for 2 years', 'interventionNames': ['Device: NIRS-IVUS Imaging (TVC Imaging System)']}], 'interventions': [{'name': 'NIRS-IVUS Imaging (TVC Imaging System)', 'type': 'DEVICE', 'description': 'Diagnostic Imaging Catheter', 'armGroupLabels': ['Participants With 2 Years Follow up']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California Los Angeles Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'city': 'Atlantis', 'state': 'Florida', 'country': 'United States', 'facility': 'JFK Medical Center', 'geoPoint': {'lat': 26.5909, 'lon': -80.10088}}, {'city': 'Delray Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Delray Medical Center', 'geoPoint': {'lat': 26.46146, 'lon': -80.07282}}, {'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Palmetto General Hospital', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Hospital Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'city': 'Palm Beach Gardens', 'state': 'Florida', 'country': 'United States', 'facility': 'Palm Beach Gardens Medical Center', 'geoPoint': {'lat': 26.82339, 'lon': -80.13865}}, {'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'Memorial Hospital West', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory Midtwon', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Elk Grove Village', 'state': 'Illinois', 'country': 'United States', 'facility': 'Alexian Brothers Heart and Vascular Institute', 'geoPoint': {'lat': 42.00392, 'lon': -87.97035}}, {'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': "St. John's Springfield", 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Community Heart & Vascular', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'city': 'Merrillville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Methodist', 'geoPoint': {'lat': 41.48281, 'lon': -87.33281}}, {'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Central Baptist Hospital', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'city': 'Bay City', 'state': 'Michigan', 'country': 'United States', 'facility': 'McLaren Bay Region', 'geoPoint': {'lat': 43.59447, 'lon': -83.88886}}, {'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': "St. John's", 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'city': 'Mount Clemens', 'state': 'Michigan', 'country': 'United States', 'facility': 'McLaren-Macomb', 'geoPoint': {'lat': 42.59726, 'lon': -82.87798}}, {'city': 'Rochester', 'state': 'Michigan', 'country': 'United States', 'facility': 'Crittenton Hospital', 'geoPoint': {'lat': 42.68059, 'lon': -83.13382}}, {'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota Medical Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'LIJ Health System', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Presbyterian Hospital Cornell', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Metrohealth', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Hillcrest Oklahoma Heart Institute', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Medical Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "St. Luke's Episcopal Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Heart Hospital Plano', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'city': 'Layton', 'state': 'Utah', 'country': 'United States', 'facility': 'Davis Hospital and Medical Center', 'geoPoint': {'lat': 41.06022, 'lon': -111.97105}}, {'city': 'Charleston', 'state': 'West Virginia', 'country': 'United States', 'facility': 'Charleston Area Medical Center', 'geoPoint': {'lat': 38.34982, 'lon': -81.63262}}, {'city': 'Rome', 'country': 'Italy', 'facility': 'San Biovanni Hospital', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Riga', 'country': 'Latvia', 'facility': 'Latvian Centre of Cardiology', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academic Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Radboud University Medical Centre', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus Medical Centre', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Maasstad Ziekenhuis', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Banská Bystrica', 'country': 'Slovakia', 'facility': 'SUSCCH, a.s.', 'geoPoint': {'lat': 48.73947, 'lon': 19.14932}}, {'city': 'Clydebank', 'country': 'United Kingdom', 'facility': 'Golden Jubilee National Hospital', 'geoPoint': {'lat': 55.90137, 'lon': -4.4057}}, {'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'University of Edinburgh', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal Brompton Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Ron Waksman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MedStar Heart Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Infraredx', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medstar Health Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}