A Registry Study on Genetics and Biomarkers of Acute Coronary Syndrome

NCT ID: NCT03752515

Last Updated: 2023-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-02

Study Completion Date

2025-10-01

Brief Summary

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

Detailed Description

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Conditions

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Coronary Artery Disease Acute Coronary Syndrome Acute Myocardial Infarction Unstable Angina

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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case-ACS-MACE

ACS patients with poor prognosis

No interventions assigned to this group

control-ACS-MACE

ACS patients with good prognosis

No interventions assigned to this group

Health-control

general population without ACS

No interventions assigned to this group

Eligibility Criteria

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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:
1. Symptoms of angina at rest or on minimal exercise and
2. At least 0.5mm ST deviation in at least 2 leads and
3. No increase in biomarkers of necrosis
4. 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.


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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing Institute of Heart, Lung and Blood Vessel Diseases

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jie Du, PHD

Role: STUDY_DIRECTOR

Beijing Anzhen Hospital

Locations

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Beijing Anzhen Hospital

Beijing, , China

Site Status

Beijing Luhe Hospital, Capital Medical University

Beijing, , China

Site Status

The First Affiliated Hospital of Dalian Medical University

Dalian, , China

Site Status

The Second Hospital of Dalian Medical University

Dalian, , China

Site Status

The First Hospital of Jilin University

Jilin, , China

Site Status

People's Hospital of Henan University

Zhengzhou, , China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 39895550 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31220942 (View on PubMed)

Other Identifiers

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BeijingIHLBVD2018010

Identifier Type: -

Identifier Source: org_study_id

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