The Lipid-Rich Plaque Study

Study Overview
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Brief Summary
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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.

Official Title
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The Lipid-Rich Plaque (LRP) Study

Conditions
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Coronary Artery Disease, Atherosclerosis

Intervention / Treatment
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* Device: NIRS-IVUS Imaging (TVC Imaging System)


Participation Criteria
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Eligibility Criteria
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General Inclusion Criteria: Subjects presenting for coronary angiography in whom IVUS imaging is likely to be performed for clinical purposes. Greater than 18 years of age. Clinical presenting symptoms meeting one of the three criteria below: Subjects presenting with an acute coronary syndrome (ACS) including at least one of the following: Elevated cardiac biomarkers with CK-MB or troponin greater than upper limits of normal; ST depression or ST elevation >1mm in 2 or more contiguous leads in the absence of LVH, paced rhythm, BBB or early repolarization; A stabilized patient 24 to 72 hours post STEMI; Unstable angina pectoris; Stable angina pectoris and/or a positive functional study with evidence of ischemia. Angiographic Inclusion Criteria At least one Suspected Index Culprit Lesion requiring imaging with IVUS and/or NIRS for clinical indications. At least two native epicardial coronary arteries (which may include the Suspected Index Culprit Artery) eligible for imaging with NIRS-IVUS. IVUS/NIRS Imaging Inclusion Criterion 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. Exclusion Criteria: 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. History of CABG or planned CABG within 6 months following NIRS-IVUS imaging. Patient has additional lesion(s) that needs a staged PCI. Subject life expectancy is less than 2 years at time of index catheterization. Subject with ejection fraction (EF) <30%. Subject pacemaker dependent/paced rhythm. Subject pregnant and lactating. 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 Patients undergoing performance of PCI in all three major vessels during the index PCI.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants With 2 Years Follow up<br>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 | Device: NIRS-IVUS Imaging (TVC Imaging System)<br>* Diagnostic Imaging Catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 Non-Index Culprit Lesion related Major Adverse Cardiac Events (NC-MACE) is defined as a composite of: cardiac death cardiac arrest non-fatal myocardial infarction (MI) acute coronary syndrome revascularization by coronary artery bypass graft (CABG) or percutaneous intervention (PCI) rehospitalization for progressive angina, related to a non-index culprit lesion | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Stratified as NC-MACE or No NC-MACE and Association With maxLCBI4mm More Than a Threshold of 400 | 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 Non-Index Culprit Lesion related Major Adverse Cardiac Events (NC-MACE) is defined as a composite of: cardiac death cardiac arrest non-fatal myocardial infarction (MI) acute coronary syndrome revascularization by coronary artery bypass graft (CABG) or percutaneous intervention (PCI) rehospitalization for progressive angina, related to a non-index culprit lesion | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lipid, Vulnerable Plaque, Plaque, Cholesterol, Near Infrared Spectroscopy, NIRS-IVUS, Intravascular Ultrasound, Angiography, Coronary Imaging