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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03479723
Other study ID # 2017P000329
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2017
Est. completion date December 2024

Study information

Verified date October 2023
Source Massachusetts General Hospital
Contact Ik-Kyung Jang, MD, PhD
Phone 617-726-9226
Email IJANG@mgh.harvard.edu
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to perform pooled analysis with data collected from 5 previously published studies and 8 unpublished datasets collected from international sites.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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

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