Status:
UNKNOWN
A Registry Study on Genetics and Biomarkers of Acute Coronary Syndrome
Lead Sponsor:
Beijing Institute of Heart, Lung and Blood Vessel Diseases
Conditions:
Coronary Artery Disease
Acute Coronary Syndrome
Eligibility:
All Genders
18-80 years
Brief Summary
This is a national registry study to determine genetics risk factors and serial biomarkers of Acute Coronary Syndrome.
Eligibility Criteria
Inclusion
- ACS Case
- 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:
- Criteria for STEMI diagnosis:
- History of chest pain/discomfort and
- 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
- Elevation of cardiac biomarkers (CK-MB, troponins): at least one value above the 99th percentile of the local laboratory upper reference limit.
- Criteria for NSTEMI diagnosis:
- 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:
- Symptoms of angina at rest or on minimal exercise and
- At least 0.5mm ST deviation in at least 2 leads and
- No increase in biomarkers of necrosis
- 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
- 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.
Key Trial Info
Start Date :
June 2 2015
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT03752515
Start Date
June 2 2015
End Date
October 1 2025
Last Update
October 26 2023
Active Locations (6)
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1
Beijing Anzhen Hospital
Beijing, China, 100029
2
Beijing Luhe Hospital, Capital Medical University
Beijing, China
3
The First Affiliated Hospital of Dalian Medical University
Dalian, China
4
The Second Hospital of Dalian Medical University
Dalian, China