Coronary RevascUlarization in Patients With End-stage Renal dIsease on dialysiS in China: a Nationwide and multicEnter Cohort Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Incidence of all-cause death
研究概览
简要总结
China patients in end stage renal disease receiving maintenance dialysis have a high risk of cardiovascular disease (CVD), with a prevalence of 45.5% approximately, and coronary artery disease (CAD) has been identified as the most common one. It remains unclear that what their treatment status is and whether this group of patients can benefit from revascularization in China. The investigators plan to recruit around 30 hospitals from 7 regions as study centers, which represent different levels of economic development in Mainland China. The detailed information includes demographics, medical history, coronary angiogram, in-hospital treatment and procedures, short-term and long-term outcomes. The aim of the study is to provide the real world knowledge about current status of coronary revascularization and prognosis in patients with CAD and dialysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 or above and 85 or below.
- •Receives peritoneal dialysis or hemodialysis more than 1-time weekly and for more than 3 months.
- •Diagnosed with coronary artery disease, including STEMI, NST-ACD, stable coronary artery disease.
排除标准
- •Pregnancy or lactation.
- •Can't be cooperative because of a mental illness or other reasons.
- •Malignant tumor or severe hepatic disease.
- •Life expectancy is less than 1 year.
结局指标
主要结局
Incidence of all-cause death
时间窗: the duration of hospital stay, an expected average of 2 weeks
All-cause deaths includes cardiac death, vascular death and non-cardiovascular death. 1. Cardiac death: any death due to proximate cardiac cause (eg, MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure-related deaths, including those related to concomitant treatment, will be classified as cardiac death. 2. Vascular death: caused by noncoronary vascular causes, such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular diseases. 3. Non-cardiovascular death: any death not covered by the above definitions, such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide, or trauma.
Incidence of all-cause death and non-fatal myocardial infarction
时间窗: 12-month follow-up
Non-fatal myocardial infarction is defined as elevated cardiac enzymes (troponin or myocardial band fraction of creatine kinase) above the upper reference limit with ischemic symptoms or electrocardiography findings indicative of ischemia that is not related to the index procedure.
次要结局
- Incidence of all-cause death and non-fatal myocardial infarction(within 30 days after discharge)
- Incidence of bleeding(12-month follow-up)
- Incidence of all-cause death, non-fatal myocardial infarction, non-fatal stroke, repeat revascularization, cardiovascular rehospitalization.(12-month follow-up)
研究者
Jingang Zheng
Department of Cardiology, China-Japan Friendship Hospital
China-Japan Friendship Hospital