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NCT Number: NCT05897333

Turkish Isolated Coronary Ectasia Registry: The T-ICE Registry

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gazi University, School of Medicine

Ankara, 06550, Turkey (Türkiye)

Location status: Recruiting

Location contact

Adnan Abaci

CONTACT

[email protected]

03122025631

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Major adverse cardiovascular and cerebrovascular events

    Time frame: Five years

    A composite endpoint of death, myocardial infarction, unstable angina, stroke, and coronary revascularization.

Secondary outcomes

  1. Major adverse cardiovascular events

    Time frame: Five years

    A composite endpoint of cardiovascular death, myocardial infarction, unstable angina, and coronary revascularization.

Study contacts

Contact information is provided by the study sponsor or research team.

Adnan Abaci

CONTACT

[email protected]

+903122025631

Emrullah Kızıltunc

CONTACT

[email protected]

+903122025629

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

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

Acronym: T-ICE

Important dates

Study start
2022
Primary completion
2032
Study completion
2032
First posted
Jun 9, 2023
Registry last updated
Jun 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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