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The Lipid-Rich Plaque Study (LRP)

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ClinicalTrials.gov Identifier: NCT02033694
Recruitment Status : Active, not recruiting
First Posted : January 13, 2014
Last Update Posted : September 18, 2018
Sponsor:
Collaborator:
Medstar Health Research Institute
Information provided by (Responsible Party):
InfraReDx

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.

Condition or disease
Coronary Artery Disease Atherosclerosis

Study Type : Observational
Actual Enrollment : 1563 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Lipid-Rich Plaque (LRP) Study
Actual Study Start Date : February 2014
Actual Primary Completion Date : April 2018
Estimated Study Completion Date : October 2018

Group/Cohort
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



Primary Outcome Measures :
  1. Non-Index Culprit Lesion related Major Adverse Cardiac Events (NC-MACE) [ Time Frame: Assess occurance of NC-MACE during 2 year follow up ]

    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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033694


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

Responsible Party: InfraReDx
ClinicalTrials.gov Identifier: NCT02033694     History of Changes
Other Study ID Numbers: The LRP Study
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

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