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Recruiting NCT05897333

Turkish Isolated Coronary Ectasia Registry: The T-ICE Registry

Observational Coronary Artery Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Coronary Artery Disease. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Major adverse cardiovascular and cerebrovascular events [Time frame: Five years]
Secondary outcome measures (1)
  • Major adverse cardiovascular events [Time frame: Five years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Case-control

Study locations

Turkey (Türkiye) · 1 center
  • Gazi University, School of Medicine — Ankara

Publications

  • 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. PMID 16415301
  • 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. PMID 15194034
  • 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. PMID 29054186
  • 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. PMID 20395236
  • 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. PMID 28648421
  • 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. PMID 24673382
  • 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. PMID 32515749

Identifiers

NCT: NCT05897333 · 03063806

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗