Clinical trial NCT03752515: A Registry Study on Genetics and Biomarkers of Acute Coronary Syndrome
Official title: A Chinese Registry to Determine the Genetics Risk Factors and Serumal Biomarkers for Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Coronary Artery Disease
Acute Coronary Syndrome
Acute Myocardial Infarction
Unstable Angina
Lead sponsor: Beijing Institute of Heart, Lung and Blood Vessel Diseases
Sponsor class: OTHER
First posted: 2018-11-26
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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


Eligibility 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.

Control Inclusion Criteria:

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

Primary outcomes:
measure: Age for each participant
timeFrame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: Gender for each participant
timeFrame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: Height for each participant
timeFrame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: Weight for each participant
timeFrame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: Contact information for each participant
timeFrame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: Past Medical History
timeFrame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: Lifestyle
timeFrame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: Biochemical
timeFrame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: Biomarkers
timeFrame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: Overall lesion profiles
timeFrame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: Echocardiography
timeFrame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: Medication at discharge
timeFrame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: Genetic data
timeFrame: Sequencing will be carried out in an average of 3 months after sample recruiting
measure: Metabolomic profile on Liquid Chromatograph Mass Spectrometer/Mass Spectrometer analysis of serum sample.
timeFrame: The data is collected from lab in an average of 3 month after the sample recruiting
measure: Detection of miRNAs expression in each participant using the qRT-PCT method.
timeFrame: The data is collected from lab in an average of 3 month after the sample recruiting
measure: Detection of candidate biomarkers in each participant using proteome detection or ELASA
timeFrame: The data is collected from lab in an average of 12 month after the sample recruiting
measure: 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.
timeFrame: These data is collected during follow-up visit after discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
city: Beijing
country: China
facility: Beijing Luhe Hospital, Capital Medical University
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
city: Dalian
country: China
facility: The Second Hospital of Dalian Medical University
city: Jilin
country: China
facility: The First Hospital of Jilin University
city: Zhengzhou
country: China
facility: People's Hospital of Henan University
Study officials:
affiliation: Beijing Anzhen Hospital
name: Jie Du, PHD
role: STUDY_DIRECTOR
References:
citation: 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.