Acute Coronary Syndrome Clinical Trial
Official title:
BIomarker-based Prognostic Assessment for Patients With Stable Angina and Acute Coronary Syndromes (BIPass)
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.
Status | Recruiting |
Enrollment | 10000 |
Est. completion date | December 31, 2020 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: 1. 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) 2. Age =18 years of age and <85 years of age 3. Patient or guardian provided informed written consent Exclusion Criteria: 1. Prior surgery (cardiac or non-cardiac), trauma or clinically evident coagulopathic bleeding (e.g. gastrointestinal, genitourinary, et al) 2. Patient with non-cardiac co-morbidities with life expectancy less than 12 months 3. Patients unwilling or unable to comply with all clinical follow-up schedules at 30 days, 6 months and 12 months after discharge |
Country | Name | City | State |
---|---|---|---|
China | Qilu Hospital, Shandong University | Jinan | Shandong |
Lead Sponsor | Collaborator |
---|---|
Qilu Hospital of Shandong University | Central Hospital of Zibo, Chinese PLA General Hospital Hospital, Peking University First Hospital, Peking University Third Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Major Adverse Cardiac Events | a composite of cardiac death, myocardial infarction or stroke | 12 months | |
Primary | Major bleeding | BARC 3 or more bleeding | 12 months |
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