Overview

This trial is active, not recruiting.

Conditions coronary artery disease, atherosclerosis
Sponsor InfraReDx
Collaborator Medstar Research Institute
Start date January 2014
End date March 2018
Trial size 1562 participants
Trial identifier NCT02033694, The LRP Study

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
TVC (NIRS-IVUS) diagnostic imaging used to identify Large LRP
TVC (NIRS-IVUS) diagnostic imaging used to identify Small/No LRP
TVC (NIRS-IVUS) diagnostic imaging used to identify Small/No LRP

Primary Outcomes

Measure
Non-Index Culprit Lesion related Major Adverse Cardiac Events (NC-MACE)
time frame: Assess occurance of NC-MACE during 2 year follow up

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

Official title The Lipid-Rich Plaque (LRP) Study
Principal investigator Ron Waksman, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by InfraReDx.