Identification of Predictors for Coronary Plaque Erosion in Patients With Acute Coronary Syndrome
Study Details
Study Description
Brief 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The purpose of this study is to perform pooled analysis with data collected from 5 previously published studies and 8 unpublished datasets collected from international sites.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.
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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 Design
Outcome Measures
Primary Outcome Measures
- Cardiac death [3-year]
Secondary Outcome Measures
- all cause death [3-year]
- myocardial infarction [3-year]
- stent thrombosis [3-year]
stent thrombosis was defined according to the Academic Research Consortium criteria
- any target lesion revascularization [3-year]
Any revascularization due to thrombosis or restenosis of the target lesion
- clinically driven target lesion revascularization [3-year]
target lesion revascularization performed because of ischemic symptoms, electrocardiographic changes at rest or positive stress test relists
- target-vessel revascularization [3-year]
Revascularization of any segment of the coronary artery containing the target lesion
- any repeat revascularization [3-year]
- stroke [3-year]
- device-oriented composite (cardiac death, target vessel MI, and TLR) [3-year]
- bleeding complication [3-year]
Gusto and BARC definition
- patients-oriented composite (all cause death, MI, any repeat coronary revascularization) [3-year]
- target vessel failure (TVF; cardiac death, MI, or ischemia-driven TVR) [3-year]
- major adverse cardiac events (MACEs: cardiac death, MI, or ischemia-driven TLR) [3-year]
Eligibility Criteria
Criteria
Inclusion Criteria:
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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).
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Intra-vascular OCT imaging of culprit vessel.
Exclusion Criteria:
- None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
Sponsors and Collaborators
- Massachusetts General Hospital
Investigators
- Principal Investigator: Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2017P000329