BHAS: Beijing Hospital Atherosclerosis Study

Sponsor
Beijing Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03072797
Collaborator
(none)
3,000
1
69.5
43.2

Study Details

Study Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
3000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Beijing Hospital Atherosclerosis Study
Actual Study Start Date :
Mar 16, 2017
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Outcome Measures

Primary Outcome Measures

  1. Number of participants with major adverse cardiovascular events (MACE) [3 years]

    MACE include death from any cause, nonfatal myocardial infarction, nonfatal stroke and revascularization.

Secondary Outcome Measures

  1. Number of participants with other atherosclerosis events [3 years]

    Other atherosclerosis events include readmission for angin and transient ischemic attack.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bejing Hosptial Beijing Beijing China 100730

Sponsors and Collaborators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Fusui Ji, MD, Director, Department of Gerontological Cardiology, Beijing Hospital
ClinicalTrials.gov Identifier:
NCT03072797
Other Study ID Numbers:
  • 2016BJYYEC-121-02
First Posted:
Mar 7, 2017
Last Update Posted:
Apr 27, 2022
Last Verified:
Apr 1, 2022
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
Keywords provided by Fusui Ji, MD, Director, Department of Gerontological Cardiology, Beijing Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 27, 2022