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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

January 8, 2014
January 13, 2014
September 18, 2018
February 2014
April 2018   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT02033694 on ClinicalTrials.gov Archive Site
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Not Provided
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The Lipid-Rich Plaque Study
The Lipid-Rich Plaque (LRP) Study
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.
Not Provided
Observational
Observational Model: Case-Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
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.
  • Coronary Artery Disease
  • Atherosclerosis
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1563
9000
October 2018
April 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
Italy,   Latvia,   Netherlands,   Slovakia,   United Kingdom,   United States
 
 
NCT02033694
The LRP Study
Yes
Not Provided
Plan to Share IPD: Undecided
InfraReDx
InfraReDx
Medstar Health Research Institute
Principal Investigator: Ron Waksman, MD MedStar Heart Institute
InfraReDx
September 2018