Turkish Isolated Coronary Ectasia Registry: The T-ICE Registry

Sponsor

Gazi University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05897333

Collaborator

(none)

3,000

Enrollment

Location

120

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

3000 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Turkish Isolated Coronary Ectasia Prospective Cohort Study: the T-ICE Registry

Actual Study Start Date :

Mar 15, 2022

Anticipated Primary Completion Date :

Mar 15, 2032

Anticipated Study Completion Date :

Mar 15, 2032

Arms and Interventions

Arm	Intervention/Treatment
Isolated coronary ectasia Includes the patients with isolated coronary artery ectasia without coronary stenosis.
Coronary artery disease Includes the patients with ≥50% stenosis in a vessel ≥2 mm in diameter.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gazi University, School of Medicine	Ankara		Turkey	06550

Sponsors and Collaborators

Gazi University

Investigators

Principal Investigator: Adnan Abaci, Gazi University, School of Medicine, Department of Cardiology

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Adnan Abacı, MD, Prof. Dr., Gazi University

ClinicalTrials.gov Identifier:

NCT05897333

Other Study ID Numbers:

03063806

First Posted:

Jun 9, 2023

Last Update Posted:

Jun 9, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Coronary Artery Disease

Study Results

No Results Posted as of Jun 9, 2023