NCT03072797

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 7, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

March 16, 2017

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

April 27, 2022

Status Verified

April 1, 2022

Enrollment Period

5.8 years

First QC Date

February 27, 2017

Last Update Submit

April 20, 2022

Conditions

AtherosclerosisCardiovascular DiseasesCoronary Artery DiseaseMyocardial IschemiaStroke

Keywords

AtherosclerosisLongitudinalBiomarkerCoronary angiographyFollow-upMetabolomicsRisk factor

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Number of participants with other atherosclerosis events

    3 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bejing Hosptial

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (4)

  • 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.

    PMID: 18279733BACKGROUND

  • 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.

    PMID: 28007146BACKGROUND

  • Wang Y, Yang R, Zhang Y, Wang Z, Wang X, Wang S, Zhang W, Yu X, Dong J, Chen W, Ji F. Prognostic Value of Serum 1,5-anhydroglucitol Levels in Patients with Acute Myocardial Infarction. Rev Cardiovasc Med. 2022 Dec 2;23(12):394. doi: 10.31083/j.rcm2312394. eCollection 2022 Dec.

    PMID: 39076658DERIVED

  • 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.

    PMID: 36133308DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood, 10 mL (whole blood, plasma, serum)

MeSH Terms

Conditions

AtherosclerosisCardiovascular DiseasesCoronary Artery DiseaseMyocardial IschemiaStroke

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCoronary DiseaseHeart DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruiyue Yang, M.D.

CONTACT

+861058115049yangruiyue4057@bjhmoh.cn

Wenduo Zhang, M.D.

CONTACT

+861085136232zhangwenduo3103@bjhmoh.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Department of Gerontological Cardiology

Study Record Dates

First Submitted

February 27, 2017

First Posted

March 7, 2017

Study Start

March 16, 2017

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

April 27, 2022

Record last verified: 2022-04

Locations

CN(1)