The Lipid-Rich Plaque Study

NCT02033694 | Completed Results DMC

• 1 other identifier: The LRP Study
• Study Type: observational
• Target: 1,563
• Locations: 6 countries
• Sites: 41

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.

Conditions

Coronary Artery Disease; Atherosclerosis

Keywords

Lipid; Vulnerable Plaque; Plaque; Cholesterol; Near Infrared Spectroscopy; NIRS-IVUS; Intravascular Ultrasound; Angiography; Coronary Imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Participants Stratified as NC-MACE or No NC-MACE and Association With maxLCBI4mm More Than a Threshold of 400

  2 years

Study Arms (1)

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)

Interventions

NIRS-IVUS Imaging (TVC Imaging System) DEVICE

Diagnostic Imaging Catheter

Participants With 2 Years Follow up

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Infraredx: lead
• Medstar Health Research Institute: collaborator

Study Sites (41)

University of California Los Angeles Medical Center

Los Angeles, California, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, United States

Location

JFK Medical Center

Atlantis, Florida, United States

Location

Delray Medical Center

Delray Beach, Florida, United States

Location

Palmetto General Hospital

Hialeah, Florida, United States

Location

Florida Hospital Orlando

Orlando, Florida, United States

Location

Palm Beach Gardens Medical Center

Palm Beach Gardens, Florida, United States

Location

Memorial Hospital West

Pembroke Pines, Florida, United States

Location

Emory Midtwon

Atlanta, Georgia, United States

Location

Emory University

Atlanta, Georgia, United States

Location

Alexian Brothers Heart and Vascular Institute

Elk Grove Village, Illinois, United States

Location

St. John's Springfield

Springfield, Illinois, United States

Location

Community Heart & Vascular

Indianapolis, Indiana, United States

Location

Methodist

Merrillville, Indiana, United States

Location

Central Baptist Hospital

Lexington, Kentucky, United States

Location

McLaren Bay Region

Bay City, Michigan, United States

Location

St. John's

Detroit, Michigan, United States

Location

McLaren-Macomb

Mount Clemens, Michigan, United States

Location

Crittenton Hospital

Rochester, Michigan, United States

Location

University of Minnesota Medical Center

Minneapolis, Minnesota, United States

Location

Columbia University

New York, New York, United States

Location

LIJ Health System

New York, New York, United States

Location

New York Presbyterian Hospital Cornell

New York, New York, United States

Location

Metrohealth

Cleveland, Ohio, United States

Location

Hillcrest Oklahoma Heart Institute

Tulsa, Oklahoma, United States

Location

Medical University of South Carolina

Charleston, South Carolina, United States

Location

University of Texas Medical Branch

Galveston, Texas, United States

Location

St. Luke's Episcopal Hospital

Houston, Texas, United States

Location

Heart Hospital Plano

Plano, Texas, United States

Location

Davis Hospital and Medical Center

Layton, Utah, United States

Location

Charleston Area Medical Center

Charleston, West Virginia, United States

Location

San Biovanni Hospital

Rome, Italy

Location

Latvian Centre of Cardiology

Riga, Latvia

Location

Academic Medical Center

Amsterdam, Netherlands

Location

Radboud University Medical Centre

Nijmegen, Netherlands

Location

Erasmus Medical Centre

Rotterdam, Netherlands

Location

Maasstad Ziekenhuis

Rotterdam, Netherlands

Location

SUSCCH, a.s.

Banská Bystrica, Slovakia

Location

Golden Jubilee National Hospital

Clydebank, United Kingdom

Location

University of Edinburgh

Edinburgh, United Kingdom

Location

Royal Brompton Hospital

London, United Kingdom

Location

Related Publications (8)

• 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: 28938968 BACKGROUND

• 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: 31570255 BACKGROUND

• 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: 37271594 DERIVED

• 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: 36058829 DERIVED

• 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: 35842005 DERIVED

• 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: 34972665 DERIVED

• 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: 34465457 DERIVED

• 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.

  PMID: 34455112 DERIVED

Related Links

• The Lipid-Rich Plaque Study of vulnerable plaques and vulnerable patients: Study design and rationale. Am Heart J. 2017
• Identification of patients and plaques vulnerable to future coronary events with near-infrared spectroscopy intravascular ultrasound imaging: a prospective, cohort study. Lancet. 2019

MeSH Terms

Conditions

Coronary Artery Disease; Atherosclerosis; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Priti Shah
• Organization: Infraredx, A Nipro Company

pshah@infraredx.com

781-345-9646

Study Officials

• Ron Waksman, MD

  MedStar Heart Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2014
• First Posted: January 13, 2014
• Study Start: February 1, 2014
• Primary Completion: April 1, 2018
• Study Completion: September 1, 2018
• Last Updated: May 19, 2020
• Results First Posted: May 19, 2020

Record last verified: 2020-05

Locations

IT (1); SL (1); US (31); LA (1); GB (3); NL (4)