The Lipid-Rich Plaque Study (LRP)
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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 |
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Recruitment Status :
Completed
First Posted : January 13, 2014
Results First Posted : May 19, 2020
Last Update Posted : May 19, 2020
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| Condition or disease | Intervention/treatment |
|---|---|
| Coronary Artery Disease Atherosclerosis | Device: NIRS-IVUS Imaging (TVC Imaging System) |
| 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 |
| Actual Study Completion Date : | September 2018 |
| Group/Cohort | Intervention/treatment |
|---|---|
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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
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Device: NIRS-IVUS Imaging (TVC Imaging System)
Diagnostic Imaging Catheter |
- 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
- 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
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.
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | 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.
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.
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.
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Clinical presenting symptoms meeting one of the three criteria below:
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Subjects presenting with an acute coronary syndrome (ACS) including at least one of the following:
- Elevated cardiac biomarkers with CK-MB or troponin greater than upper limits of normal;
- ST depression or ST elevation >1mm in 2 or more contiguous leads in the absence of LVH, paced rhythm, BBB or early repolarization;
- A stabilized patient 24 to 72 hours post STEMI;
- Unstable angina pectoris;
- Stable angina pectoris and/or a positive functional study with evidence of ischemia.
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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.
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
Show 41 study locations
| Principal Investigator: | Ron Waksman, MD | MedStar Heart Institute |
Documents provided by Infraredx:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Infraredx |
| ClinicalTrials.gov Identifier: | NCT02033694 |
| Other Study ID Numbers: |
The LRP Study |
| First Posted: | January 13, 2014 Key Record Dates |
| Results First Posted: | May 19, 2020 |
| Last Update Posted: | May 19, 2020 |
| Last Verified: | May 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
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Lipid Vulnerable Plaque Plaque Cholesterol Near Infrared Spectroscopy |
NIRS-IVUS Intravascular Ultrasound Angiography Coronary Imaging |
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Coronary Artery Disease Atherosclerosis Coronary Disease Myocardial Ischemia Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |