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Trial record 1 of 1 for:    NCT02033694
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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. Identifier: NCT02033694
Recruitment Status : Active, not recruiting
First Posted : January 13, 2014
Last Update Posted : September 18, 2018
Medstar Health Research Institute
Information provided by (Responsible Party):

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

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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 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

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, Learn About Clinical Studies.

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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.

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 identifier (NCT number): NCT02033694

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Sponsors and Collaborators
Medstar Health Research Institute
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Principal Investigator: Ron Waksman, MD MedStar Heart Institute

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: InfraReDx Identifier: NCT02033694    
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:
Vulnerable Plaque
Near Infrared Spectroscopy
Intravascular Ultrasound
Coronary Imaging
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases