Beijing Hospital Atherosclerosis Study (BHAS)

The Beijing Hospital Atherosclerosis Study (BHAS) is a prospective, single-center, observational cohort study performed at the Beijing Hospital in Beijing, China. Subjects enrolled in this study will be the consecutive patients undergoing coronary angiography in the hospital. Blood samples are taken immediately before the angiographic procedure. Clinical and angiographic characteristics are recorded. All patients will have routine follow-up at 6 months and 1 year postprocedure, then yearly thereafter. Follow-up includes mortality, myocardial infarction (MI), stroke, rehospitalization, coronary revascularization procedures, life styles, and medication use. The primary end point for the study will be the major adverse cardiovascular events (MACE), defined as death from any cause, nonfatal myocardial infarction, nonfatal stroke and revascularization. This study has been reviewed and approved by the Ethics Committee of Beijing Hospital. All enrolled individuals will be received written notice of the intended use of their blood samples and provided written consent.

The major objectives of the BHAS Study are to (1) establish a prospective cohort and a biological sample bank in ethnic Chinese with coronary angiography, (2) identify baseline new biosignature profiles such as novel biomarkers via metabolomics approach associated with the subsequent clinical events, (3) assess the use of molecular profiles from multiple platforms (eg, genomics, proteomics, and metabolomics) integrated with readily available clinical information for improved risk classification for cardiovascular events, and (4) provide clearer understanding of underlying disease processes.

Study Overview

• Status: Recruiting
• Conditions: Myocardial Ischemia; Cardiovascular Diseases; Coronary Artery Disease; Stroke; Atherosclerosis

• Study Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

• Study Contact: Name: Ruiyue Yang, M.D.; Phone Number: +861058115049; Email: yangruiyue4057@bjhmoh.cn
• Study Contact Backup: Name: Wenduo Zhang, M.D.; Phone Number: +861085136232; Email: zhangwenduo3103@bjhmoh.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Bejing Hosptial
      • Contact: Ruiyue Yang, M.D.; Phone Number: +861058115049; Email: yangruiyue4057@bjhmoh.cn
      • Contact: Wenduo Zhang, M.D.; Phone Number: +861085136232; Email: zhangwenduo3103@bjhmoh.cn
      • Principal Investigator: Fusui Ji, M.D.
      • Principal Investigator: Wenxiang Chen, M.D.
      • Sub-Investigator: Jun Dong, Ph.D
      • Principal Investigator: Xue Yu, M.D.
      • Sub-Investigator: Ruiyue Yang, M.D.
      • Sub-Investigator: Wenduo Zhang, M.D.
      • Sub-Investigator: Siming Wang, Ph.D.
      • Sub-Investigator: Xinyue Wang, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects enrolled in this study will be the consecutive patients undergoing coronary angiography at the Beijing Hospital in Beijing, China.

Description

Inclusion Criteria:

• Age >18y
• Consent for the study
• Primary reason for catheterization is concern for ischemic heart disease
• Complete clinical and coronary angiogram data available

Exclusion Criteria:

• Primary pulmonary hypertension or severe lung disease
• Cardiac transplantation
• Other solid organ transplant
• Peripheral vascular intervention only
• Right heart catheterization only
• Advanced heart failure
• Congenital heart disease
• Women who are pregnant or nursing, or preparing for pregnant during the study period
• Progressive fatal disease
• History of alcoholism or drug abuse
• Patients with mental illness and are being treated
• Patients are undergoing radiotherapy or chemotherapy
• Acute and chronic infectious diseases

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with major adverse cardiovascular events (MACE)	MACE include death from any cause, nonfatal myocardial infarction, nonfatal stroke and revascularization.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with other atherosclerosis events	Other atherosclerosis events include readmission for angin and transient ischemic attack.	3 years

Collaborators and Investigators

• Sponsor: Beijing Hospital
• Investigators: Principal Investigator: Fusui Ji, M.D., Department of Cardiology, Beijing Hospital,National Center of Gerontology; Principal Investigator: Wenxiang Chen, M.D., The MOH Key Laboratory of Geriatrics, Beijing Hospital, National Center of Gerontology; Principal Investigator: Xue Yu, M.D., Department of Cardiology, Beijing Hospital,National Center of Gerontology

Publications and helpful links

General Publications

• Kip KE, Hollabaugh K, Marroquin OC, Williams DO. The problem with composite end points in cardiovascular studies: the story of major adverse cardiac events and percutaneous coronary intervention. J Am Coll Cardiol. 2008 Feb 19;51(7):701-7. doi: 10.1016/j.jacc.2007.10.034.
• Ussher JR, Elmariah S, Gerszten RE, Dyck JR. The Emerging Role of Metabolomics in the Diagnosis and Prognosis of Cardiovascular Disease. J Am Coll Cardiol. 2016 Dec 27;68(25):2850-2870. doi: 10.1016/j.jacc.2016.09.972.
• Yang R, Zhang W, Wang X, Wang S, Zhou Q, Li H, Mu H, Yu X, Ji F, Dong J, Chen W. Nonlinear association of 1,5-anhydroglucitol with the prevalence and severity of coronary artery disease in chinese patients undergoing coronary angiography. Front Endocrinol (Lausanne). 2022 Sep 5;13:978520. doi: 10.3389/fendo.2022.978520. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2017
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: February 27, 2017
• First Submitted That Met QC Criteria: March 2, 2017
• First Posted (Actual): March 7, 2017

Study Record Updates

• Last Update Posted (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Biomarker; Coronary angiography; Atherosclerosis; Metabolomics; Follow-up; Longitudinal; Risk factor
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Cardiovascular Diseases; Ischemia; Atherosclerosis
• Other Study ID Numbers: 2016BJYYEC-121-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No