Identification of Predictors for Coronary Plaque Erosion in Patients With Acute Coronary Syndrome

Overview

The purpose of this study is to perform pooled analysis with data collected from 5 previously published studies and 8 unpublished datasets collected from international sites. The main goal of this study is to identify the predictors of plaque erosion.

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Other
  • Study Primary Completion Date: December 2024

Detailed Description

Plaque erosion is reported to be responsible for about one third of patients with acute coronary syndrome (ACS). In the EROSION study, we reported that antithrombotic therapy without stenting achieved a reduction in thrombus volume greater than 50% in over 70% of patients diagnosed with ACS caused by plaque erosion. This result suggests that the conservative approach of anti-thrombotic therapy without stenting may be an option for patients diagnosed with ACS caused by plaque erosion, which may be the paradigm shift in treatment of ACS patients. However, at present, the only way to make an in vivo diagnosis of plaque erosion is intra-coronary optical coherence tomography (OCT). If we can identify clinical factors associated with plaque erosion, we may be able to narrow down a sub-population of patients with a higher likelihood of plaque erosion. This group of patients may be stabilized with pharmacologic therapy and avoid invasive procedures, thereby preventing related complications and reducing health care burden. However, specific demographic characteristics of the ACS patients with plaque erosion are not known. Our group has the world's largest dataset of patients with plaque erosion and several published reports on plaque erosion. However, the study population of each study is still small and unbalanced to identify the demographic characteristics associated with plaque erosion. Therefore, we propose to pool data from a large number of institutions around the world. This will provide an opportunity to identify factors associated with plaque erosion.

Clinical Trial Outcome Measures

Primary Measures

  • Cardiac death
    • Time Frame: 3-year

Secondary Measures

  • all cause death
    • Time Frame: 3-year
  • myocardial infarction
    • Time Frame: 3-year
  • stent thrombosis
    • Time Frame: 3-year
    • stent thrombosis was defined according to the Academic Research Consortium criteria
  • any target lesion revascularization
    • Time Frame: 3-year
    • Any revascularization due to thrombosis or restenosis of the target lesion
  • clinically driven target lesion revascularization
    • Time Frame: 3-year
    • target lesion revascularization performed because of ischemic symptoms, electrocardiographic changes at rest or positive stress test relists
  • target-vessel revascularization
    • Time Frame: 3-year
    • Revascularization of any segment of the coronary artery containing the target lesion
  • any repeat revascularization
    • Time Frame: 3-year
  • stroke
    • Time Frame: 3-year
  • device-oriented composite (cardiac death, target vessel MI, and TLR)
    • Time Frame: 3-year
  • bleeding complication
    • Time Frame: 3-year
    • Gusto and BARC definition
  • patients-oriented composite (all cause death, MI, any repeat coronary revascularization)
    • Time Frame: 3-year
  • target vessel failure (TVF; cardiac death, MI, or ischemia-driven TVR)
    • Time Frame: 3-year
  • major adverse cardiac events (MACEs: cardiac death, MI, or ischemia-driven TLR)
    • Time Frame: 3-year

Participating in This Clinical Trial

Inclusion Criteria

1. Diagnosed with ACS upon admission to hospital, including patients with ST-elevation myocardial infarction (STEMI), non-ST elevation myocardial infarction (NSTEMI), and unstable angina pectoris (UAP). 2. Intra-vascular OCT imaging of culprit vessel. Exclusion Criteria:

  • None

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Massachusetts General Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ik-Kyung Jang, MD, PhD, Professor of Medicine; Director, Cardiology Laboratory for Integrative Physiology & Imaging – Massachusetts General Hospital
  • Overall Official(s)
    • Ik-Kyung Jang, MD, PhD, Principal Investigator, Massachusetts General Hospital
  • Overall Contact(s)
    • Ik-Kyung Jang, MD, PhD, 617-726-9226, IJANG@mgh.harvard.edu

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