The Lipid-Rich Plaque Study

Coronary Artery Disease Clinical Trial

— LRP  

Official title:

The Lipid-Rich Plaque (LRP) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02033694
• Other study ID #: The LRP Study
• Status: Completed
• Start date: February 2014
• Est. completion date: September 2018

Study information

• Verified date: May 2020
• Source: InfraReDx
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1563
• Est. completion date: September 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease

Intervention

Device:
• NIRS-IVUS Imaging (TVC Imaging System)
Diagnostic Imaging Catheter

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
InfraReDx	Medstar Health Research Institute

Countries where clinical trial is conducted

United States,  Italy,  Latvia,  Netherlands,  Slovakia,  United Kingdom, 

References & Publications (2)

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. Erratum in: Lancet. 2019 Nov 2;394(10209):1618. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

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