BIomarker-based Prognostic Assessment for Patients With Stable Angina and Acute Coronary Syndromes (BIPass)
试验速览
- 阶段
- 不适用
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Major Adverse Cardiac Events
研究概览
简要总结
Coronary artery disease (including stable angina and acute coronary disease) remains the leading mortality and morbidity worldwide. Improvement in biomarker, imaging research have led to new predictors for the prognosis, which may have great clinical value in the current era of personalized medicine. However, there is no available biomarker-based prediction rule for risk assessment of adverse events in patients with stable angina and acute coronary disease. Therefore, we aim to develop and validate a new biomarker-based risk model to improve the prognostication of adverse events (e.g. ischemic and bleeding events ) in the patient population.
详细描述
Patients enrolled in Qilu Hospital of Shandong University (Jinan, China), Chinese PLA General Hospital Hospital (Beijing, China) and Peking University First Hospital (Beijing, China) are designed as the development cohort to derive the risk prediction models of ischemic and bleeding events. Patients enrolled in Peking University Third Hospital ( Beijing, China) Zibo Central hospital (Zibo, China) are designed as the independent validation cohort.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized patients with the diagnosis of any type of coronary artery disease (stable angina, unstable angina, non ST-segment elevation myocardial infarction or ST-segment elevation myocardial infarction)
- •Age ≥18 years of age and <85 years of age
- •Patient or guardian provided informed written consent
排除标准
- •Prior surgery (cardiac or non-cardiac), trauma or clinically evident coagulopathic bleeding (e.g. gastrointestinal, genitourinary, et al)
- •Patient with non-cardiac co-morbidities with life expectancy less than 12 months
- •Patients unwilling or unable to comply with all clinical follow-up schedules at 30 days, 6 months and 12 months after discharge
结局指标
主要结局
Major Adverse Cardiac Events
时间窗: 12 months
a composite of cardiac death, myocardial infarction or stroke
Major bleeding
时间窗: 12 months
BARC 3 or more bleeding
次要结局
未报告次要终点