Biomarker-based Prognostic Assessment

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.

Study Overview

• Status: Unknown
• Conditions: Acute Coronary Syndrome; Stable Angina
• Intervention / Treatment: Biological: Plasma biomarker

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.

• Study Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Qilu Hospital, Shandong University
      • Contact: Yuguo Chen, MD,PhD; Phone Number: +8618678812777; Email: chen919085@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

In this prospective, multicenter registry study, we will consecutively enroll eligible patients according to the pre-specified inclusion and exclusion criteria in 6 tertiary hospitals in China. Patients meeting all eligibility criteria will be tracked and their hospitalization data will be collected including baseline clinical and demographic data, risk factors, blood drawn and storage, lab testing results, angiographic and procedural data (if appropriate), medication and adverse events. Clinical follow-up visits will be sheduled at 30 days, 6 months and 12 months after discharge by telephone contact. Follow-up data will be collected and assessment for death (cardiac, non-cardiac), myocardial infarction, stroke, revascularization or bleeding events will be conducted.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Cardiac Events	a composite of cardiac death, myocardial infarction or stroke	12 months
Major bleeding	BARC 3 or more bleeding	12 months

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University
• Collaborators: Peking University First Hospital; Peking University Third Hospital; Central Hospital of Zibo; Chinese PLA General Hospital Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 9, 2017
• Primary Completion (ANTICIPATED): December 31, 2020
• Study Completion (ANTICIPATED): December 31, 2020

Study Registration Dates

• First Submitted: August 1, 2019
• First Submitted That Met QC Criteria: August 1, 2019
• First Posted (ACTUAL): August 2, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 1, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Disease; Chest Pain; Angina Pectoris; Syndrome; Acute Coronary Syndrome; Angina, Stable
• Other Study ID Numbers: 20172020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No