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NCT05897333 Clinical Trial

Turkish Isolated Coronary Ectasia Registry: The T-ICE Registry

Coronary Artery Disease Clinical Trial

— T-ICE  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05897333
Other study ID # 03063806
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 15, 2022
Est. completion date March 15, 2032

Study information
Verified date May 2023
Source Gazi University
Contact Adnan Abaci
Phone +903122025631
Email abaci@gazi.edu.tr
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 3000
Est. completion date March 15, 2032
Est. primary completion date March 15, 2032
Accepts healthy volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Turkey Gazi University, School of Medicine Ankara

Sponsors (1)
Lead Sponsor Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

Baman TS, Cole JH, Devireddy CM, Sperling LS. Risk factors and outcomes in patients with coronary artery aneurysms. Am J Cardiol. 2004 Jun 15;93(12):1549-51. doi: 10.1016/j.amjcard.2004.03.011. — View Citation

Boles U, Zhao Y, Rakhit R, Shiu MF, Papachristidis A, David S, Koganti S, Gilbert T, Henein MY. Patterns of coronary artery ectasia and short-term outcome in acute myocardial infarction. Scand Cardiovasc J. 2014 Jun;48(3):161-6. doi: 10.3109/14017431.2014.902495. Epub 2014 Apr 10. — View Citation

Erden I, Erden EC, Ozhan H, Karabulut A, Ordu S, Yazici M. Outcome of primary percutaneous intervention in patients with infarct-related coronary artery ectasia. Angiology. 2010 Aug;61(6):574-9. doi: 10.1177/0003319709361197. Epub 2010 Apr 14. — View Citation

Malviya A, Jha PK, Mishra A. Isolated coronary artery ectasia: Clinical, angiographic, and follow up characteristics. Indian Heart J. 2017 Sep-Oct;69(5):619-623. doi: 10.1016/j.ihj.2016.12.017. Epub 2017 Jan 22. — View Citation

Manginas A, Cokkinos DV. Coronary artery ectasias: imaging, functional assessment and clinical implications. Eur Heart J. 2006 May;27(9):1026-31. doi: 10.1093/eurheartj/ehi725. Epub 2006 Jan 16. — View Citation

Vasu N, Narayanan S, Ajit MS. Clinical outcome of various management strategies in coronary artery ectasia. Indian Heart J. 2017 May-Jun;69(3):319-321. doi: 10.1016/j.ihj.2017.04.013. Epub 2017 May 4. No abstract available. — View Citation

Willner NA, Ehrenberg S, Musallam A, Roguin A. Coronary artery ectasia: prevalence, angiographic characteristics and clinical outcome. Open Heart. 2020 Apr;7(1):e001096. doi: 10.1136/openhrt-2019-001096. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Major adverse cardiovascular and cerebrovascular events A composite endpoint of death, myocardial infarction, unstable angina, stroke, and coronary revascularization. Five years
Secondary Major adverse cardiovascular events A composite endpoint of cardiovascular death, myocardial infarction, unstable angina, and coronary revascularization. Five years
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