Italian Registry on Treatment for Unprotected Left Main Disease (Registro Italiano Sul Trattamento Del Tronco coMune Non protettO)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- major adverse cerebro-cardiovascular events (ie death, myocardial infarction, stroke, or coronary revascularization)
研究概览
简要总结
The RITMO (Registro Italiano sul trattamento del Tronco coMune non protettO) observational study will appraise the prevalence, management strategy, and prognosis of unprotected left main coronary artery disease in Italy.
详细描述
The RITMO (Registro Italiano sul trattamento del Tronco coMune non protettO) observational study will be a prospective, multicenter, observational study aiming to appraise the prevalence, management strategy, and prognosis (up to 5 years) of unprotected left main coronary artery disease in Italy. A total of 45 Italian secondary and tertiary care centers will participate, and enroll patients during a period of 12 to 18 months. Patients will be included provided that they complete a written informed consent form and significant unprotected left main coronary artery disease is established at diagnostic coronary angiography. The primary end-point will be the 12-month rate of major adverse cerebro-cardiovascular events (ie death, myocardial infarction, stroke, or coronary revascularization).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •angiographic evidence of significant unprotected left main disease
- •lack of patent bypass grafts for the left coronary system
- •willingness to complete written informed consent form
- •willingness to comply with subsequent follow-up contacts
排除标准
- •lack of written informed consent form
- •inability to comply with subsequent follow-up contacts
结局指标
主要结局
major adverse cerebro-cardiovascular events (ie death, myocardial infarction, stroke, or coronary revascularization)
时间窗: 12 months
次要结局
- major adverse cerebro-cardiovascular events(60 months)
- Canadian Cardiac Society functional class(60 months)
- quality of life (EuroQoL)(60 months)