The Lipid-Rich Plaque Study (LRP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by InfraReDx
Sponsor:
Collaborator:
Medstar Research Institute
Information provided by (Responsible Party):
InfraReDx
ClinicalTrials.gov Identifier:
NCT02033694
First received: January 8, 2014
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

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.


Condition
Coronary Artery Disease
Atherosclerosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Lipid-Rich Plaque (LRP) Study

Resource links provided by NLM:


Further study details as provided by InfraReDx:

Primary Outcome Measures:
  • Non-Index Culprit Lesion related Major Adverse Cardiac Events (NC-MACE) [ Time Frame: Assess occurance of NC-MACE during 2 year follow up ] [ Designated as safety issue: Yes ]

    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


Estimated Enrollment: 9000
Study Start Date: January 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group A: Large LRP with 2 year follow up
TVC (NIRS-IVUS) diagnostic imaging used to identify Large LRP
Group B: Small/No LRP with 2 year follow up
TVC (NIRS-IVUS) diagnostic imaging used to identify Small/No LRP
Group B: Small or NO LRP without follow up
TVC (NIRS-IVUS) diagnostic imaging used to identify Small/No LRP

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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. The total study enrollment will be 9000 patients.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02033694

Contacts
Contact: Priti Shah, MS, CCRA pshah@infraredx.com
Contact: Tania Medeiros, MPH, CCRA tmedeiros@infraredx.com

Locations
United States, District of Columbia
Washington Hospital Center Recruiting
Washington, District of Columbia, United States
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States
United States, Illinois
St. John's Springfield Recruiting
Springfield, Illinois, United States
United States, Indiana
Community Heart & Vascular Recruiting
Indianapolis, Indiana, United States
Methodist Recruiting
Merrillville, Indiana, United States
United States, Kentucky
Central Baptist Hospital Recruiting
Lexington, Kentucky, United States
United States, Michigan
St. John's Recruiting
Detroit, Michigan, United States
Crittenton Hospital Recruiting
Rochester, Michigan, United States
United States, New York
Columbia University Recruiting
New York, New York, United States
United States, South Carolina
Medical University of South Carolina Recruiting
Chareston, South Carolina, United States
United States, West Virginia
Charleston Area Medical Center Recruiting
Charleston, West Virginia, United States
Sponsors and Collaborators
InfraReDx
Medstar Research Institute
Investigators
Principal Investigator: Ron Waksman, MD MedStar Heart Institute
  More Information

No publications provided

Responsible Party: InfraReDx
ClinicalTrials.gov Identifier: NCT02033694     History of Changes
Other Study ID Numbers: The LRP Study
Study First Received: January 8, 2014
Last Updated: June 5, 2014
Health Authority: United States: Data and Safety Monitoring Board

Keywords provided by InfraReDx:
Lipid
Vulnerable Plaque
Plaque
Cholesterol
Near Infrared Spectroscopy
NIRS-IVUS
Intravascular Ultrasound
Angiography
Coronary Imaging

Additional relevant MeSH terms:
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on July 29, 2014