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

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03479723
• Other study ID #: 2017P000329
• Status: Recruiting
• 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
• 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The purpose of this study is to perform pooled analysis with data collected from 5 previously published studies and 8 unpublished datasets collected from international sites.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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

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