Clinical trial NCT02033694: The Lipid-Rich Plaque Study
Official title: The Lipid-Rich Plaque (LRP) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Atherosclerosis
Keywords: Lipid
Vulnerable Plaque
Plaque
Cholesterol
Near Infrared Spectroscopy
NIRS-IVUS
Intravascular Ultrasound
Angiography
Coronary Imaging
Lead sponsor: Infraredx
Sponsor class: INDUSTRY
Collaborators: name: Medstar Health Research Institute
First posted: 2014-01-13
Enrollment: 1563
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.


Eligibility criteria: 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.

Primary outcomes:
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
timeFrame: 2 years
Secondary outcomes:
measure: Number of Participants Stratified as NC-MACE or No NC-MACE and Association With maxLCBI4mm More Than a Threshold of 400
timeFrame: 2 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California Los Angeles Medical Center
state: California
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Atlantis
country: United States
facility: JFK Medical Center
state: Florida
city: Delray Beach
country: United States
facility: Delray Medical Center
state: Florida
city: Hialeah
country: United States
facility: Palmetto General Hospital
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Orlando
state: Florida
city: Palm Beach Gardens
country: United States
facility: Palm Beach Gardens Medical Center
state: Florida
city: Pembroke Pines
country: United States
facility: Memorial Hospital West
state: Florida
city: Atlanta
country: United States
facility: Emory Midtwon
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Elk Grove Village
country: United States
facility: Alexian Brothers Heart and Vascular Institute
state: Illinois
city: Springfield
country: United States
facility: St. John's Springfield
state: Illinois
city: Indianapolis
country: United States
facility: Community Heart & Vascular
state: Indiana
city: Merrillville
country: United States
facility: Methodist
state: Indiana
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: Bay City
country: United States
facility: McLaren Bay Region
state: Michigan
city: Detroit
country: United States
facility: St. John's
state: Michigan
city: Mount Clemens
country: United States
facility: McLaren-Macomb
state: Michigan
city: Rochester
country: United States
facility: Crittenton Hospital
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center
state: Minnesota
city: New York
country: United States
facility: Columbia University
state: New York
city: New York
country: United States
facility: LIJ Health System
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital Cornell
state: New York
city: Cleveland
country: United States
facility: Metrohealth
state: Ohio
city: Tulsa
country: United States
facility: Hillcrest Oklahoma Heart Institute
state: Oklahoma
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Houston
country: United States
facility: St. Luke's Episcopal Hospital
state: Texas
city: Plano
country: United States
facility: Heart Hospital Plano
state: Texas
city: Layton
country: United States
facility: Davis Hospital and Medical Center
state: Utah
city: Charleston
country: United States
facility: Charleston Area Medical Center
state: West Virginia
city: Rome
country: Italy
facility: San Biovanni Hospital
city: Riga
country: Latvia
facility: Latvian Centre of Cardiology
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Centre
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Centre
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
city: Banska Bystrica
country: Slovakia
facility: SUSCCH, a.s.
city: Clydebank
country: United Kingdom
facility: Golden Jubilee National Hospital
city: Edinburgh
country: United Kingdom
facility: University of Edinburgh
city: London
country: United Kingdom
facility: Royal Brompton Hospital
Study officials:
affiliation: MedStar Heart Institute
name: Ron Waksman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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. 2023 Jan;46:38-43. doi: 10.1016/j.carrev.2022.08.008. Epub 2022 Aug 6.
citation: 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.
citation: 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.
citation: 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.
citation: 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.