Biomarker-based Prognostic Assessment

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04044066
• Other study ID #: 20172020
• Status: Recruiting
• Start date: November 9, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2020
• Source: Qilu Hospital of Shandong University
• Contact: Yuguo Chen, MD,PhD
• Phone: +8618678812777
• Email: chen919085[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina, Stable
• Stable Angina
• Syndrome

Intervention

Biological:
• Plasma biomarker
New emerging plasma biomarkers carrying prognositic information

Locations

Country	Name	City	State
China	Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (5)

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

Country where clinical trial is conducted

China, 

Outcome

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