Clinical trial NCT05897333: Turkish Isolated Coronary Ectasia Registry: The T-ICE Registry
Official title: Turkish Isolated Coronary Ectasia Prospective Cohort Study: the T-ICE Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2023-06-09
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with "isolated" coronary ectasia in at least one coronary artery in their first coronary angiography performed for any reason will be included in the study.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Major adverse cardiovascular and cerebrovascular events
timeFrame: Five years
Secondary outcomes:
measure: Major adverse cardiovascular events
timeFrame: Five years
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University, School of Medicine
Study officials:
affiliation: Gazi University, School of Medicine, Department of Cardiology
name: Adnan Abaci
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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.
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.
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.