Turkish Isolated Coronary Ectasia Registry: The T-ICE Registry

Recruiting

• Conditions: Coronary Artery Disease

• Registration Number: NCT05897333
• Lead Sponsor: Gazi University

Brief Summary

The T-ICE study is a prospective, observational study aiming to have information about the treatment and long-term prognosis of patients with isolated coronary artery ectasia.

Detailed Description

Coronary artery ectasia is a localized or diffuse enlargement of the coronary artery lumen ≥1.5-2 times relative to the normal segment. It is often associated with coronary artery stenosis. Some patients have coronary artery ectasia without stenosis. This condition is called as isolated coronary artery ectasia. There is data other than retrospective studies with a small number of cases on the clinical significance, prognosis and treatment of isolated coronary ectasia in patients with or without acute coronary syndrome. Therefore, the treatment of patients with isolated coronary ectasia is not evidence-based and is based on the clinical judgment of physicians. The aim of this prospective observational study is to evaluate the treatment and prognosis of the isolated coronary artery ectasia. The second aim is to compare the prognosis of isolated coronary ectasia with the coronary artery disease.

Study Timeline

• Study Start: 2022-03-15
• Study First Submitted: 2023-02-22
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-31
• Last Update Submitted: 2023-05-31
• Study First Posted: 2023-06-09
• Last Update Posted: 2023-06-09
• Primary Completion: 2032-03-15
• Study Completion: 2032-03-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• Isolated coronary artery ectasia (without ≥20% stenosis in any coronary artery ≥2 mm in diameter).
• All patients with isolated coronary ectasia with or without acute coronary syndrome will be included.
• Patients aged ≥18 years.
• Patients with discrete coronary artery aneurysm will be included.

Exclusion Criteria

• Life expectancy <24 months
• Patients with ≥20% stenosis in a vessel ≥2 mm in diameter.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major adverse cardiovascular and cerebrovascular events	Five years	A composite endpoint of death, myocardial infarction, unstable angina, stroke, and coronary revascularization.

Secondary Outcome Measures

Name	Time	Method
Major adverse cardiovascular events	Five years	A composite endpoint of cardiovascular death, myocardial infarction, unstable angina, and coronary revascularization.

Trial Locations

Locations (1)

Gazi University, School of Medicine; 🇹🇷 Ankara, Turkey