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AtherosclerosisBHASNCT03072797

Beijing Hospital Atherosclerosis Study

An observational study of Atherosclerosis and Cardiovascular Diseases, run by Beijing Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
How many people
3,000 participants
Where
1 siteChina
Study dates
16 Mar 2017to 31 Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • Primary pulmonary hypertension or severe lung disease
  • Cardiac transplantation
  • Other solid organ transplant
  • Peripheral vascular intervention only
  • Right heart catheterization only
  • Advanced heart failure
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Ruiyue Yang, M.D. contact

+861058115049

yangruiyue4057@bjhmoh.cn

Wenduo Zhang, M.D. contact

+861085136232

zhangwenduo3103@bjhmoh.cn

China1 site, 1 recruiting

  • Bejing Hosptial

    Beijing, Beijing Municipality, 100730

    Ruiyue Yang, M.D., +861058115049, yangruiyue4057@bjhmoh.cn

    Wenduo Zhang, M.D., +861085136232, zhangwenduo3103@bjhmoh.cn

    Recruiting

Other trials in China

About this study

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.

Keywords
Atherosclerosis, Longitudinal, Biomarker, Coronary angiography, Follow-up, Metabolomics, Risk factor
Medical subject headings
Atherosclerosis, Cardiovascular Diseases, Coronary Artery Disease, Myocardial Ischemia, Stroke

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with major adverse cardiovascular events (MACE)

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

    Measured: 3 years

Secondary outcomes (1)

  1. Number of participants with other atherosclerosis events

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

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2017
  2. Study start16 Mar 2017
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03072797
Sponsor's protocol ID
2016BJYYEC-121-02
Acronym
BHAS
Status last verified
Apr 2022
First submitted
27 Feb 2017
Last updated
27 Apr 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 18279733

  • 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.

    PubMed 28007146

  • 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.

    PubMed 39076658

  • 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.

    PubMed 36133308

Questions about this trial

What is this clinical trial studying?

An observational study of Atherosclerosis and Cardiovascular Diseases, run by Beijing Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ruiyue Yang, M.D. (+861058115049, yangruiyue4057@bjhmoh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with major adverse cardiovascular events (MACE) (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03072797, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.

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Beijing Hospital Atherosclerosis Study (NCT03072797) | AzTrials