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Completed

NCT Number: NCT03479723

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

The purpose of this study is to perform pooled analysis with data collected from 5 previously published studies and 8 unpublished datasets collected from international sites.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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).
  • Intra-vascular OCT imaging of culprit vessel.

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Cardiac death

    Time frame: 3-year

Secondary outcomes

  1. all cause death

    Time frame: 3-year

  2. myocardial infarction

    Time frame: 3-year

  3. stent thrombosis

    Time frame: 3-year

    stent thrombosis was defined according to the Academic Research Consortium criteria

  4. any target lesion revascularization

    Time frame: 3-year

    Any revascularization due to thrombosis or restenosis of the target lesion

  5. 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

  6. target-vessel revascularization

    Time frame: 3-year

    Revascularization of any segment of the coronary artery containing the target lesion

  7. any repeat revascularization

    Time frame: 3-year

  8. stroke

    Time frame: 3-year

  9. device-oriented composite (cardiac death, target vessel MI, and TLR)

    Time frame: 3-year

  10. bleeding complication

    Time frame: 3-year

    Gusto and BARC definition

  11. patients-oriented composite (all cause death, MI, any repeat coronary revascularization)

    Time frame: 3-year

  12. target vessel failure (TVF; cardiac death, MI, or ischemia-driven TVR)

    Time frame: 3-year

  13. major adverse cardiac events (MACEs: cardiac death, MI, or ischemia-driven TLR)

    Time frame: 3-year

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2024
First posted
Mar 27, 2018
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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