Beijing Hospital Atherosclerosis Study

Stroke Clinical Trial

— BHAS  

Official title:

Beijing Hospital Atherosclerosis Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03072797
• Other study ID #: 2016BJYYEC-121-02
• Status: Recruiting
• Start date: March 16, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2022
• Source: Beijing Hospital
• Contact: Ruiyue Yang, M.D.
• Phone: +861058115049
• Email: yangruiyue4057[@]bjhmoh.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Diseases
• Coronary Artery Disease
• Ischemia
• Myocardial Ischemia
• Stroke

Locations

Country	Name	City	State
China	Bejing Hosptial	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of participants with other atherosclerosis events	Other atherosclerosis events include readmission for angin and transient ischemic attack.	3 years