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The Lipid-Rich Plaque Study (LRP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02033694
Recruitment Status : Completed
First Posted : January 13, 2014
Results First Posted : May 19, 2020
Last Update Posted : May 19, 2020
Sponsor:
Collaborator:
Medstar Health Research Institute
Information provided by (Responsible Party):
InfraReDx

Tracking Information
First Submitted Date January 8, 2014
First Posted Date January 13, 2014
Results First Submitted Date April 13, 2020
Results First Posted Date May 19, 2020
Last Update Posted Date May 19, 2020
Actual Study Start Date February 2014
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 6, 2020)
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 [ Time Frame: 2 years ]
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
Original Primary Outcome Measures
 (submitted: January 9, 2014)
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
Change History
Current Secondary Outcome Measures
 (submitted: May 6, 2020)
Number of Participants Stratified as NC-MACE or No NC-MACE and Association With maxLCBI4mm More Than a Threshold of 400 [ Time Frame: 2 years ]
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
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Lipid-Rich Plaque Study
Official Title The Lipid-Rich Plaque (LRP) Study
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

Condition
  • Coronary Artery Disease
  • Atherosclerosis
Intervention Device: NIRS-IVUS Imaging (TVC Imaging System)
Diagnostic Imaging Catheter
Study Groups/Cohorts 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
Intervention: Device: NIRS-IVUS Imaging (TVC Imaging System)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 16, 2018)
1563
Original Estimated Enrollment
 (submitted: January 9, 2014)
9000
Actual Study Completion Date September 2018
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy,   Latvia,   Netherlands,   Slovakia,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02033694
Other Study ID Numbers The LRP Study
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party InfraReDx
Study Sponsor InfraReDx
Collaborators Medstar Health Research Institute
Investigators
Principal Investigator: Ron Waksman, MD MedStar Heart Institute
PRS Account InfraReDx
Verification Date May 2020