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

December 22, 2025 updated by: Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital
The purpose of this study is to perform pooled analysis with data collected from 5 previously published studies and 8 unpublished datasets collected from international sites.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 Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

1793

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with diagnosis of ACS confirmed by OCT imaging of the culprit lesion.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cardiac death
Time Frame: 3-year
3-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
myocardial infarction
Time Frame: 3-year
3-year
all cause death
Time Frame: 3-year
3-year
stent thrombosis
Time Frame: 3-year
stent thrombosis was defined according to the Academic Research Consortium criteria
3-year
any target lesion revascularization
Time Frame: 3-year
Any revascularization due to thrombosis or restenosis of the target lesion
3-year
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
3-year
target-vessel revascularization
Time Frame: 3-year
Revascularization of any segment of the coronary artery containing the target lesion
3-year
any repeat revascularization
Time Frame: 3-year
3-year
stroke
Time Frame: 3-year
3-year
device-oriented composite (cardiac death, target vessel MI, and TLR)
Time Frame: 3-year
3-year
bleeding complication
Time Frame: 3-year
Gusto and BARC definition
3-year
patients-oriented composite (all cause death, MI, any repeat coronary revascularization)
Time Frame: 3-year
3-year
target vessel failure (TVF; cardiac death, MI, or ischemia-driven TVR)
Time Frame: 3-year
3-year
major adverse cardiac events (MACEs: cardiac death, MI, or ischemia-driven TLR)
Time Frame: 3-year
3-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

August 1, 2024

Study Registration Dates

First Submitted

March 14, 2018

First Submitted That Met QC Criteria

March 25, 2018

First Posted (Actual)

March 27, 2018

Study Record Updates

Last Update Posted (Estimated)

December 29, 2025

Last Update Submitted That Met QC Criteria

December 22, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017P000329

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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