BIomarker-based Prognostic Assessment for Patients With Stable Angina and Acute Coronary Syndromes (BIPass)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Acute Coronary Syndrome
- Sponsor
- Qilu Hospital of Shandong University
- Enrollment
- 10000
- Locations
- 1
- Primary Endpoint
- Major Adverse Cardiac Events
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Major Adverse Cardiac Events
Time Frame: 12 months
a composite of cardiac death, myocardial infarction or stroke
Major bleeding
Time Frame: 12 months
BARC 3 or more bleeding