NCT05051917招募中不适用
ITAlian Coronary Artery Aneurysm and Ectasia Observational Study in Patients With Acute Coronary Syndrome: The ITACA Registry
Federico II University2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2021年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Major adverse cardiac events
研究概览
简要总结
The ITACA study is a prospective, observational no profit registry enrolling patients with Acute Coronary Syndrome and angiographic evidence of coronary aneurysms and/or ectasia.
详细描述
The ITACA study is aimed at evaluating short and long term outcomes in patients with acute coronary sindrome and angiographic evidence of coronary aneurysm and/or actasia. Data regarding safety and effectiveness of invasive and pharmacological treatment strategies will be also collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signature of informed consent;
- •Patients aged ≥18 years;
- •diagnosis of ACS (ST-elevation myocardial infarction, non ST-elevation myocardial infarction, unstable angina), in accordance with the definition provided in the latest guidelines;
- •diagnosis of ectasia or coronary aneurysm according to the definitions contained in this protocol, either in the culprit vessel of the SCA than in another vessel. Coronary pseudoaneurysms are excluded.
排除标准
- •impossibility or unwillingness to provide signed informed consent;
- •contraindications to dual antiplatelet therapy;
- •contraindications to anticoagulant therapy;
- •active bleeding or severe anemia (Hb <6 g / dl);
- •life expectancy <12 months;
- •female patients with potential pregnancy;
结局指标
主要结局
Major adverse cardiac events
时间窗: two years
A composite endpoint of myocardial infarction, stroke, cardiovascular death, myocardial revascularization and hospitalisation due to cardiovascular events
次要结局
未报告次要终点
研究者
Giovanni Esposito
Professor of Cardiology
Federico II University
研究点 (2)
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