The Lipid-Rich Plaque Study

Completed

Conditions: Coronary Artery Disease
Atherosclerosis

Interventions: Device: NIRS-IVUS Imaging (TVC Imaging System)

Registration Number: NCT02033694

Lead Sponsor: Infraredx

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1563

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:
1. Subjects presenting with an acute coronary syndrome (ACS) including at least one of the following:
  1. Elevated cardiac biomarkers with CK-MB or troponin greater than upper limits of normal;
  2. ST depression or ST elevation >1mm in 2 or more contiguous leads in the absence of LVH, paced rhythm, BBB or early repolarization;
  3. A stabilized patient 24 to 72 hours post STEMI;
2. Unstable angina pectoris;
3. 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.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants With 2 Years Follow up	NIRS-IVUS Imaging (TVC Imaging System)	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

Primary Outcome Measures

Name	Time	Method
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	2 years	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

Secondary Outcome Measures

Name	Time	Method
Number of Participants Stratified as NC-MACE or No NC-MACE and Association With maxLCBI4mm More Than a Threshold of 400	2 years	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

Trial Locations

Locations (41): Delray Medical Center
🇺🇸
Delray Beach, Florida, United States
University of California Los Angeles Medical Center
🇺🇸
Los Angeles, California, United States
Palmetto General Hospital
🇺🇸
Hialeah, Florida, United States
Palm Beach Gardens Medical Center
🇺🇸
Palm Beach Gardens, Florida, United States
Memorial Hospital West
🇺🇸
Pembroke Pines, Florida, United States
Emory Midtwon
🇺🇸
Atlanta, Georgia, United States
Emory University
🇺🇸
Atlanta, Georgia, United States
St. John's Springfield
🇺🇸
Springfield, Illinois, United States
Alexian Brothers Heart and Vascular Institute
🇺🇸
Elk Grove Village, Illinois, United States
Methodist
🇺🇸
Merrillville, Indiana, United States
McLaren Bay Region
🇺🇸
Bay City, Michigan, United States
McLaren-Macomb
🇺🇸
Mount Clemens, Michigan, United States
Crittenton Hospital
🇺🇸
Rochester, Michigan, United States
LIJ Health System
🇺🇸
New York, New York, United States
Columbia University
🇺🇸
New York, New York, United States
New York Presbyterian Hospital Cornell
🇺🇸
New York, New York, United States
Metrohealth
🇺🇸
Cleveland, Ohio, United States
Hillcrest Oklahoma Heart Institute
🇺🇸
Tulsa, Oklahoma, United States
University of Texas Medical Branch
🇺🇸
Galveston, Texas, United States
St. Luke's Episcopal Hospital
🇺🇸
Houston, Texas, United States
Heart Hospital Plano
🇺🇸
Plano, Texas, United States
Davis Hospital and Medical Center
🇺🇸
Layton, Utah, United States
Radboud University Medical Centre
🇳🇱
Nijmegen, Netherlands
Golden Jubilee National Hospital
🇬🇧
Clydebank, United Kingdom
SUSCCH, a.s.
🇸🇰
Banska Bystrica, Slovakia
Maasstad Ziekenhuis
🇳🇱
Rotterdam, Netherlands
Washington Hospital Center
🇺🇸
Washington, District of Columbia, United States
Latvian Centre of Cardiology
🇱🇻
Riga, Latvia
Charleston Area Medical Center
🇺🇸
Charleston, West Virginia, United States
Academic Medical Center
🇳🇱
Amsterdam, Netherlands
JFK Medical Center
🇺🇸
Atlantis, Florida, United States
Erasmus Medical Centre
🇳🇱
Rotterdam, Netherlands
University of Edinburgh
🇬🇧
Edinburgh, United Kingdom
San Biovanni Hospital
🇮🇹
Rome, Italy
Florida Hospital Orlando
🇺🇸
Orlando, Florida, United States
Community Heart & Vascular
🇺🇸
Indianapolis, Indiana, United States
Central Baptist Hospital
🇺🇸
Lexington, Kentucky, United States
St. John's
🇺🇸
Detroit, Michigan, United States
University of Minnesota Medical Center
🇺🇸
Minneapolis, Minnesota, United States
Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States
Royal Brompton Hospital
🇬🇧
London, United Kingdom