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Biomarker-based Prognostic Assessment

BIomarker-based Prognostic Assessment for Patients With Stable Angina and Acute Coronary Syndromes (BIPass)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04044066
Enrollment
10000
Registered
2019-08-02
Start date
2017-11-09
Completion date
2020-12-31
Last updated
2020-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome, Stable Angina

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.

Interventions

BIOLOGICALPlasma biomarker

New emerging plasma biomarkers carrying prognositic information

Sponsors

Peking University Third Hospital
CollaboratorOTHER
Chinese PLA General Hospital Hospital
CollaboratorUNKNOWN
Peking University First Hospital
CollaboratorOTHER
Central Hospital of Zibo
CollaboratorOTHER
Qilu Hospital of Shandong University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Major Adverse Cardiac Events12 monthsa composite of cardiac death, myocardial infarction or stroke
Major bleeding12 monthsBARC 3 or more bleeding

Countries

China

Contacts

Primary ContactYuguo Chen, MD,PhD
chen919085@126.com+8618678812777

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026