跳至主要内容
临床试验/NCT05897333
NCT05897333招募中不适用

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

Gazi University1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2022年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
3,000
试验地点
1
主要终点
Major adverse cardiovascular and cerebrovascular events

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Life expectancy <24 months
  • Patients with ≥20% stenosis in a vessel ≥2 mm in diameter.

结局指标

主要结局

Major adverse cardiovascular and cerebrovascular events

时间窗: Five years

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

次要结局

  • Major adverse cardiovascular events(Five years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adnan Abacı, MD

Prof. Dr.

Gazi University

研究点 (1)

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