Coronary Artery DiseaseLRPNCT02033694
The Lipid-Rich Plaque Study
An observational study of Coronary Artery Disease and Atherosclerosis, run by Infraredx at 41 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease, Atherosclerosis
- What is being tested?
- NIRS-IVUS Imaging (TVC Imaging System)
- Type of treatment
- Medical device
- How many people
- 1,563 participants
- Where
- 41 sitesin 6 countries
- Study dates
- Feb 2014to Sep 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
41 sites in 6 countries.
41 sites in 6 countries
United States31 sites
Emory Midtwon
Atlanta, Georgia
Emory University
Atlanta, Georgia
JFK Medical Center
Atlantis, Florida
McLaren Bay Region
Bay City, Michigan
Medical University of South Carolina
Charleston, South Carolina
Charleston Area Medical Center
Charleston, West Virginia
Metrohealth
Cleveland, Ohio
Delray Medical Center
Delray Beach, Florida
St. John's
Detroit, Michigan
Alexian Brothers Heart and Vascular Institute
Elk Grove Village, Illinois
University of Texas Medical Branch
Galveston, Texas
Palmetto General Hospital
Hialeah, Florida
St. Luke's Episcopal Hospital
Houston, Texas
Community Heart & Vascular
Indianapolis, Indiana
Davis Hospital and Medical Center
Layton, Utah
Central Baptist Hospital
Lexington, Kentucky
University of California Los Angeles Medical Center
Los Angeles, California
Methodist
Merrillville, Indiana
University of Minnesota Medical Center
Minneapolis, Minnesota
McLaren-Macomb
Mount Clemens, Michigan
Columbia University
New York, New York
LIJ Health System
New York, New York
New York Presbyterian Hospital Cornell
New York, New York
Florida Hospital Orlando
Orlando, Florida
Palm Beach Gardens Medical Center
Palm Beach Gardens, Florida
Memorial Hospital West
Pembroke Pines, Florida
Heart Hospital Plano
Plano, Texas
Crittenton Hospital
Rochester, Michigan
St. John's Springfield
Springfield, Illinois
Hillcrest Oklahoma Heart Institute
Tulsa, Oklahoma
Washington Hospital Center
Washington D.C., District of Columbia
Netherlands4 sites
Academic Medical Center
Amsterdam
Radboud University Medical Centre
Nijmegen
Erasmus Medical Centre
Rotterdam
Maasstad Ziekenhuis
Rotterdam
United Kingdom3 sites
Golden Jubilee National Hospital
Clydebank
University of Edinburgh
Edinburgh
Royal Brompton Hospital
London
About this study
Official title: 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.
- Conditions
- Coronary Artery Disease, Atherosclerosis
- Being tested
- NIRS-IVUS Imaging (TVC Imaging System)
- Keywords
- Lipid, Vulnerable Plaque, Plaque, Cholesterol, Near Infrared Spectroscopy, NIRS-IVUS, Intravascular Ultrasound, Angiography, Coronary Imaging
- Medical subject headings
- Coronary Artery Disease, Atherosclerosis, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRS-IVUS Imaging (TVC Imaging System)Device
Diagnostic Imaging Catheter
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: NIRS-IVUS Imaging (TVC Imaging System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
Measured: 2 years
Secondary outcomes (1)
Number of Participants Stratified as NC-MACE or No NC-MACE and Association With maxLCBI4mm More Than a Threshold of 400
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionApr 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,563 participants (actual)
Sponsor and investigators
- Lead sponsor
- Infraredx
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medstar Health Research Institute
- Responsible party
- Sponsor
- Investigators
- Ron Waksman, MD, Principal investigator, MedStar Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033694
- Sponsor's protocol ID
- The LRP Study
- Acronym
- LRP
- Status last verified
- May 2020
- First submitted
- 8 Jan 2014
- Last updated
- 19 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 28938968Waksman 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.
PubMed 31570255Torguson R, Mintz GS, Di Mario C, Ten Cate T, Ali ZA, Singh V, Skinner W, Zhang C, Shea C, Kuku KO, Garcia-Garcia HM, Waksman R. Disparities among Black and White patients in plaque burden and composition and long-term impact. Cardiovasc Revasc Med. 2023 Oct;55:28-32. doi: 10.1016/j.carrev.2023.04.023. Epub 2023 May 1.
PubMed 37271594Case 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. 2023 Jan;46:38-43. doi: 10.1016/j.carrev.2022.08.008. Epub 2022 Aug 6.
PubMed 36058829Torguson 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.
PubMed 35842005Case 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.
PubMed 34972665Torguson 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.
PubMed 34465457Bambagioni 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.
PubMed 34455112
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Lipid-Rich Plaque (LRP) Study
- ClinicalTrials.gov ID
- NCT02033694
- Acronym / sponsor ID
- LRP / The LRP Study
- Conditions
- Coronary Artery Disease, Atherosclerosis
- Keywords
- Lipid, Vulnerable Plaque, Plaque, Cholesterol, Near Infrared Spectroscopy, NIRS-IVUS, Intravascular Ultrasound, Angiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,563 participants (actual)
- Lead sponsor
- InfraredxIndustry (pharma, biotech, devices)
- Collaborators
- Medstar Health Research Institute
- Study start
- Feb 2014 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 13 Jan 2014 (estimated)
- Results
- Posted 19 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants With 2 Years Follow up | – | Device: NIRS-IVUS Imaging (TVC Imaging System)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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- 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%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIRS-IVUS Imaging (TVC Imaging System)Diagnostic Imaging Catheter | Device | Participants With 2 Years Follow up |
Primary outcome
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
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28938968Waksman 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.
- Background: PubMed 31570255Waksman 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.
- Derived from this study: PubMed 37271594Torguson R, Mintz GS, Di Mario C, Ten Cate T, Ali ZA, Singh V, Skinner W, Zhang C, Shea C, Kuku KO, Garcia-Garcia HM, Waksman R. Disparities among Black and White patients in plaque burden and composition and long-term impact. Cardiovasc Revasc Med. 2023 Oct;55:28-32. doi: 10.1016/j.carrev.2023.04.023. Epub 2023 May 1.
- Derived from this study: PubMed 36058829Case 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. 2023 Jan;46:38-43. doi: 10.1016/j.carrev.2022.08.008. Epub 2022 Aug 6.
- Derived from this study: PubMed 35842005Torguson 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.
- Derived from this study: PubMed 34972665Case 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.
- Derived from this study: PubMed 34465457Torguson 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.
- Derived from this study: PubMed 34455112Bambagioni 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.
- The Lipid-Rich Plaque Study of vulnerable plaques and vulnerable patients: Study design and rationale. Am Heart J. 2017Link provided by the sponsor.
- Identification of patients and plaques vulnerable to future coronary events with near-infrared spectroscopy intravascular ultrasound imaging: a prospective, cohort study. Lancet. 2019Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ron Waksman, MD principal investigator
MedStar Heart Institute
41 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Atherosclerosis, run by Infraredx at 41 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Netherlands, United Kingdom, Italy, Latvia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02033694, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2020.