AzTrials
AzTrials

Coronary Artery DiseaseARSGB-ACSNCT03752515

A Registry Study on Genetics and Biomarkers of Acute Coronary Syndrome

An observational study of Coronary Artery Disease and Acute Coronary Syndrome, run by Beijing Institute of Heart, Lung and Blood Vessel Diseases at 6 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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
Search all trials

Trial summary

This is a national registry study to determine genetics risk factors and serial biomarkers of Acute Coronary Syndrome. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
How many people
2,000 participants
Where
6 sitesChina
Study dates
2 Jun 2015to 1 Oct 2025
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 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Case-ACS-MACE group consists of patients who was diagnosed as Acute Coronary Syndrome and had a poor prognosis during follow up. Control-ACS-MACE group consists of patients who was diagnosed as Acute Coronary Syndrome and had a good prognosis during follow up. Health control group is general population without Acute Coronary Syndrome.

ACS Case Inclusion Criteria:

  • Written informed consent has been provided.
  • Contact Order Form has been provided.
  • Aged 18 years or older.
  • Hospitalized within 48 hours of onset of symptoms.
  • Diagnosis of STEMI, NSTEMI or UA using the following definitions: 1.Criteria for STEMI diagnosis:
  1. History of chest pain/discomfort and
  2. Persistent ST-segment elevation (> 30 min) of ≥ 0.1 mV in 2 or more contiguous ECG leads or presumed new left bundle branch block (LBBB) on admission and
  3. Elevation of cardiac biomarkers (CK-MB, troponins): at least one value above the 99th percentile of the local laboratory upper reference limit. 2.Criteria for NSTEMI diagnosis: 1.History of chest pain/discomfort and 2.Lack of persistent ST-segment elevation, LBBB or intraventricular conduction disturbances and 3.Elevation of cardiac biomarkers (CK-MB, troponins): at least one value above the 99th percentile of the local laboratory upper reference limit. 3.Criteria for Unstable Angina diagnosis:
  4. Symptoms of angina at rest or on minimal exercise and
  5. At least 0.5mm ST deviation in at least 2 leads and
  6. No increase in biomarkers of necrosis
  7. OR objective evidence of ischaemia by non-invasive imaging OR significant coronary stenosis as determined by the treating physician at angiography if this is standard practice in study site. Case Exclusion Criteria: Patients will not be eligible to participate if any of the following exclusion criteria are present:
  • UA, STEMI and NSTEMI precipitated by or as a complication of surgery, trauma, or GI bleeding or post-PCI.
  • UA, STEMI and NSTEMI occurring in patients already hospitalized for other reasons.
  • Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker or does not understand the local language, psychiatric disturbances).
  • Presence of serious/severe co-morbidities in the opinion of the investigator which may limit short term (i.e. 6 month) life expectancy.
  • Current participation in a randomised interventional clinical trial.

Control Inclusion Criteria:

  • Age and gender are matched with cases.
  • No Coronary Artery Disease was detected by Coronary CT examination.
  • Normal biochemical indicators.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • Beijing Anzhen Hospital

    Beijing, 100029

  • Beijing Luhe Hospital, Capital Medical University

    Beijing

  • The First Affiliated Hospital of Dalian Medical University

    Dalian

  • The Second Hospital of Dalian Medical University

    Dalian

  • The First Hospital of Jilin University

    Jilin City

  • People's Hospital of Henan University

    Zhengzhou

Other trials in China

About this study

Official title: A Chinese Registry to Determine the Genetics Risk Factors and Serumal Biomarkers for Acute Coronary Syndrome

This is a national registry study to determine genetics risk factors and serial biomarkers of Acute Coronary Syndrome.

Medical subject headings
Coronary Artery Disease, Acute Coronary Syndrome, Angina, Unstable

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03752515
Study groupRoleWhat they receive
case-ACS-MACEACS patients with poor prognosis
control-ACS-MACEACS patients with good prognosis
Health-controlgeneral population without ACS

What is being measured

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

  1. Age for each participant

    current age and onset age

    Measured: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting

  2. Gender for each participant

    male or female

    Measured: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting

  3. Height for each participant

    cm cm cm

    Measured: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting

  4. Weight for each participant

    kg

    Measured: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting

  5. Contact information for each participant

    telephone

    Measured: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting

  6. Past Medical History

    including disease history, surgical history, and medical history

    Measured: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting

  7. Lifestyle

    including smoking history and drinking, specify how many years smoking or drinking lasted and detail quantity per day

    Measured: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting

  8. Biochemical

    including blood lipid, fasting glucose, Creatinine and so on

    Measured: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting

  9. Biomarkers

    including cTnI, BNP, hs-CRP, and so on

    Measured: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting

  10. Overall lesion profiles

    how many vessels involved

    Measured: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting

  11. Echocardiography

    LVEF and so on

    Measured: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting

  12. Medication at discharge

    Measured: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting

  13. Genetic data

    Exon sequencing data or genotypes of candidate SNPs

    Measured: Sequencing will be carried out in an average of 3 months after sample recruiting

  14. Metabolomic profile on Liquid Chromatograph Mass Spectrometer/Mass Spectrometer analysis of serum sample.

    The results of metabolomics will be measured by mass spectrometry, including lipids, sugars, amino acids, carnitine, choline, arachidonic acid, sterol and free fat acid . All of metabolites will be quantitative (unit: mol/L). Identification of molecules via Human Metabolites Database will be reported online.

    Measured: The data is collected from lab in an average of 3 month after the sample recruiting

  15. Detection of miRNAs expression in each participant using the qRT-PCT method.

    Relative expression levels of miRNA were analyzed using the 2-△Ct method and U6 was used as an endogenous control.

    Measured: The data is collected from lab in an average of 3 month after the sample recruiting

  16. Detection of candidate biomarkers in each participant using proteome detection or ELASA

    Measured: The data is collected from lab in an average of 12 month after the sample recruiting

  17. Major adverse cardiovascular events (MACE) in overall population, defined as composite of all-cause death, Heart Failure, recurrent myocardial infarction, stroke or ischemia-driven revascularization.

    HF includes in-hospital and long-term post-discharge HF incidence

    Measured: These data is collected during follow-up visit after discharge

Timeline

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

  1. First posted26 Nov 2018
  2. Study start2 Jun 2015
  3. Primary completion1 Jun 2021
  4. Study completion1 Oct 2025 (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
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03752515
Sponsor's protocol ID
BeijingIHLBVD2018010
Acronym
ARSGB-ACS
Status last verified
Oct 2023
First submitted
31 Oct 2018
Last updated
26 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Ma J, Ma K, Chen J, Yang X, Gao F, Gao H, Zhang H, Ma XL, Du J, Li P, Li Y. Development and Validation of Risk Stratification for Heart Failure After Acute Coronary Syndrome Based on Dynamic S100A8/A9 Levels. J Am Heart Assoc. 2025 Feb 4;14(3):e037401. doi: 10.1161/JAHA.124.037401. Epub 2025 Feb 3.

    PubMed 39895550

  • Li Y, Chen B, Yang X, Zhang C, Jiao Y, Li P, Liu Y, Li Z, Qiao B, Bond Lau W, Ma XL, Du J. S100a8/a9 Signaling Causes Mitochondrial Dysfunction and Cardiomyocyte Death in Response to Ischemic/Reperfusion Injury. Circulation. 2019 Aug 27;140(9):751-764. doi: 10.1161/CIRCULATIONAHA.118.039262. Epub 2019 Jun 21.

    PubMed 31220942

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and Acute Coronary Syndrome, run by Beijing Institute of Heart, Lung and Blood Vessel Diseases at 6 sites in China.

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

Who may be eligible to take part?

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 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Age for each participant (time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting). The study lists 17 primary outcomes in all. 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 NCT03752515, which also lists 2 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 26 Oct 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in