The Lipid-Rich Plaque Study (LRP)

May 6, 2020 updated by: Infraredx

The Lipid-Rich Plaque (LRP) Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1563

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

All 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.

Description

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:

    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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants With 2 Years Follow up
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)
Diagnostic Imaging Catheter

What is the study measuring?

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
Time Frame: 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
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
Time Frame: 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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Infraredx

Collaborators

Medstar Health Research Institute

Investigators

  • Principal Investigator: Ron Waksman, MD, MedStar Heart Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2014

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

January 8, 2014

First Submitted That Met QC Criteria

January 9, 2014

First Posted (Estimate)

January 13, 2014

Study Record Updates

Last Update Posted (Actual)

May 19, 2020

Last Update Submitted That Met QC Criteria

May 6, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The LRP Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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