A Registry Study on Genetics and Biomarkers of Acute Coronary Syndrome (ARSGB-ACS)

Beijing Institute of Heart, Lung and Blood Vessel Diseases

Status

Active, not recruiting

Conditions

Coronary Artery Disease

Unstable Angina

Acute Coronary Syndrome

Acute Myocardial Infarction

Study type

Observational

Funder types

Other

Identifiers

NCT03752515

BeijingIHLBVD2018010

Details and patient eligibility

About

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

Enrollment

2,000 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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:
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.
  
  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.