Clinical trial NCT03072797: Beijing Hospital Atherosclerosis Study
Official title: Beijing Hospital Atherosclerosis Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atherosclerosis
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Stroke
Keywords: Atherosclerosis
Longitudinal
Biomarker
Coronary angiography
Follow-up
Metabolomics
Risk factor
Lead sponsor: Beijing Hospital
Sponsor class: OTHER_GOV
First posted: 2017-03-07
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with major adverse cardiovascular events (MACE)
timeFrame: 3 years
Secondary outcomes:
measure: Number of participants with other atherosclerosis events
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Bejing Hosptial
state: Beijing
Study officials:
affiliation: Department of Cardiology, Beijing Hospital,National Center of Gerontology
name: Fusui Ji, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The MOH Key Laboratory of Geriatrics, Beijing Hospital, National Center of Gerontology
name: Wenxiang Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiology, Beijing Hospital,National Center of Gerontology
name: Xue Yu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: 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.