- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02033694
The Lipid-Rich Plaque Study (LRP)
The Lipid-Rich Plaque (LRP) Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Rome, Italy
- San Biovanni Hospital
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Riga, Latvia
- Latvian Centre of Cardiology
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Amsterdam, Netherlands
- Academic Medical Center
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Nijmegen, Netherlands
- Radboud University Medical Centre
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Rotterdam, Netherlands
- Maasstad Ziekenhuis
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Rotterdam, Netherlands
- Erasmus Medical Centre
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Banska Bystrica, Slovakia
- SUSCCH, a.s.
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Clydebank, United Kingdom
- Golden Jubilee National Hospital
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Edinburgh, United Kingdom
- University of Edinburgh
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London, United Kingdom
- Royal Brompton Hospital
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California
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Los Angeles, California, United States
- University of California Los Angeles Medical Center
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District of Columbia
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Washington, District of Columbia, United States
- Washington Hospital Center
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Florida
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Atlantis, Florida, United States
- JFK Medical Center
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Delray Beach, Florida, United States
- Delray Medical Center
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Hialeah, Florida, United States
- Palmetto General Hospital
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Orlando, Florida, United States
- Florida Hospital Orlando
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Palm Beach Gardens, Florida, United States
- Palm Beach Gardens Medical Center
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Pembroke Pines, Florida, United States
- Memorial Hospital West
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Georgia
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Atlanta, Georgia, United States
- Emory University
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Atlanta, Georgia, United States
- Emory Midtwon
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Illinois
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Elk Grove Village, Illinois, United States
- Alexian Brothers Heart and Vascular Institute
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Springfield, Illinois, United States
- St. John's Springfield
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Indiana
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Indianapolis, Indiana, United States
- Community Heart & Vascular
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Merrillville, Indiana, United States
- Methodist
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Kentucky
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Lexington, Kentucky, United States
- Central Baptist Hospital
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Michigan
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Bay City, Michigan, United States
- McLaren Bay Region
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Detroit, Michigan, United States
- St. John's
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Mount Clemens, Michigan, United States
- McLaren-Macomb
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Rochester, Michigan, United States
- Crittenton Hospital
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Minnesota
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Minneapolis, Minnesota, United States
- University of Minnesota Medical Center
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New York
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New York, New York, United States
- Columbia University
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New York, New York, United States
- LIJ Health System
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New York, New York, United States
- New York Presbyterian Hospital Cornell
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Ohio
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Cleveland, Ohio, United States
- MetroHealth
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Oklahoma
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Tulsa, Oklahoma, United States
- Hillcrest Oklahoma Heart Institute
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South Carolina
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Charleston, South Carolina, United States
- Medical University of South Carolina
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Texas
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Galveston, Texas, United States
- University of Texas Medical Branch
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Houston, Texas, United States
- St. Luke's Episcopal Hospital
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Plano, Texas, United States
- Heart Hospital Plano
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Utah
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Layton, Utah, United States
- Davis Hospital and Medical Center
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West Virginia
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Charleston, West Virginia, United States
- Charleston Area Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
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:
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.
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
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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Diagnostic Imaging Catheter
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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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:
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2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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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:
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2 years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ron Waksman, MD, MedStar Heart Institute
Publications and helpful links
General Publications
- Waksman R, Di Mario C, Torguson R, Ali ZA, Singh V, Skinner WH, Artis AK, Cate TT, Powers E, Kim C, Regar E, Wong SC, Lewis S, Wykrzykowska J, Dube S, Kazziha S, van der Ent M, Shah P, Craig PE, Zou Q, Kolm P, Brewer HB, Garcia-Garcia HM; LRP Investigators. Identification of patients and plaques vulnerable to future coronary events with near-infrared spectroscopy intravascular ultrasound imaging: a prospective, cohort study. Lancet. 2019 Nov 2;394(10209):1629-1637. doi: 10.1016/S0140-6736(19)31794-5. Epub 2019 Sep 27. Erratum In: Lancet. 2019 Nov 2;394(10209):1618.
- Waksman R, Torguson R, Spad MA, Garcia-Garcia H, Ware J, Wang R, Madden S, Shah P, Muller J. The Lipid-Rich Plaque Study of vulnerable plaques and vulnerable patients: Study design and rationale. Am Heart J. 2017 Oct;192:98-104. doi: 10.1016/j.ahj.2017.02.010. Epub 2017 Feb 16.
- Case BC, Torguson R, Mintz GS, Di Mario C, Medranda GA, Zhang C, Shea C, Garcia-Garcia HM, Waksman R. Additive effect of multiple high-risk coronary artery segments on patient outcomes: LRP Study sub-analysis. Cardiovasc Revasc Med. 2022 Aug 6:S1553-8389(22)00704-7. doi: 10.1016/j.carrev.2022.08.008. Online ahead of print.
- Torguson R, Mintz GS, Case BC, Di Mario C, Zhang C, Shea C, Garcia-Garcia HM, Waksman R. Correlation between lipidic content and arterial-wall plaque burden: A Lipid Rich Plaque study sub-analysis. Int J Cardiol. 2022 Nov 1;366:32-34. doi: 10.1016/j.ijcard.2022.07.024. Epub 2022 Jul 13.
- Case BC, Shea C, Torguson R, Zhang C, Yerasi C, Medranda GA, Kuku KO, Garcia-Garcia HM, Mintz GS, Waksman R. Impact of Baseline Imaging of Non-Culprit Coronary Lesions on Adverse Events: Insight From LRP Study. Cardiovasc Revasc Med. 2022 Jun;39:1-5. doi: 10.1016/j.carrev.2021.12.012. Epub 2021 Dec 13.
- Torguson R, Shlofmitz E, Mintz GS, Mario CD, Cate TT, Ali ZA, Singh V, Skinner W, Zhang C, Shea C, Garcia-Garcia HM, Waksman R. Frequency of Lipid-Rich Coronary Plaques in Stable Angina Pectoris versus Acute Coronary Syndrome (from the Lipid Rich Plaque Study). Am J Cardiol. 2021 Nov 1;158:1-5. doi: 10.1016/j.amjcard.2021.07.033. Epub 2021 Aug 28.
- Bambagioni G, Di Mario C, Torguson R, Demola P, Ali Z, Singh V, Skinner W, Artis A, Cate TT, Zhang C, Garcia-Garcia HM, Doros G, Mintz GS, Waksman R. Lipid-rich plaques detected by near-infrared spectroscopy predict coronary events irrespective of age: A Lipid Rich Plaque sub-study. Atherosclerosis. 2021 Oct;334:17-22. doi: 10.1016/j.atherosclerosis.2021.08.022. Epub 2021 Aug 14.
Helpful Links
- The Lipid-Rich Plaque Study of vulnerable plaques and vulnerable patients: Study design and rationale. Am Heart J. 2017
- Identification of patients and plaques vulnerable to future coronary events with near-infrared spectroscopy intravascular ultrasound imaging: a prospective, cohort study. Lancet. 2019
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- The LRP Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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