A Registry Study on Genetics and Biomarkers of Acute Coronary Syndrome

Study Overview
=================
Brief Summary
-----------------
This is a national registry study to determine genetics risk factors and serial biomarkers of Acute Coronary Syndrome.

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

Conditions
-----------------
Coronary Artery Disease, Acute Coronary Syndrome, Acute Myocardial Infarction, Unstable Angina

Participation Criteria
=================
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: 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. 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: 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 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| case-ACS-MACE<br>ACS patients with poor prognosis | |
| control-ACS-MACE<br>ACS patients with good prognosis | |
| Health-control<br>general population without ACS | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age for each participant | current age and onset age | These data is collected from the cases' medical record in an average of 1 month after the sample recruiting | 
| Gender for each participant | male or female | These data is collected from the cases' medical record in an average of 1 month after the sample recruiting | 
| Height for each participant | cm cm cm | These data is collected from the cases' medical record in an average of 1 month after the sample recruiting | 
| Weight for each participant | kg | These data is collected from the cases' medical record in an average of 1 month after the sample recruiting | 
| Contact information for each participant | telephone | These data is collected from the cases' medical record in an average of 1 month after the sample recruiting | 
| Past Medical History | including disease history, surgical history, and medical history | These data is collected from the cases' medical record in an average of 1 month after the sample recruiting | 
| Lifestyle | including smoking history and drinking, specify how many years smoking or drinking lasted and detail quantity per day | These data is collected from the cases' medical record in an average of 1 month after the sample recruiting | 
| Biochemical | including blood lipid, fasting glucose, Creatinine and so on | These data is collected from the cases' medical record in an average of 1 month after the sample recruiting | 
| Biomarkers | including cTnI, BNP, hs-CRP, and so on | These data is collected from the cases' medical record in an average of 1 month after the sample recruiting | 
| Overall lesion profiles | how many vessels involved | These data is collected from the cases' medical record in an average of 1 month after the sample recruiting | 
| Echocardiography | LVEF and so on | These data is collected from the cases' medical record in an average of 1 month after the sample recruiting | 
| Medication at discharge |  | These data is collected from the cases' medical record in an average of 1 month after the sample recruiting | 
| Genetic data | Exon sequencing data or genotypes of candidate SNPs | Sequencing will be carried out in an average of 3 months after sample recruiting | 
| 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. | The data is collected from lab in an average of 3 month after the sample recruiting | 
| 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. | The data is collected from lab in an average of 3 month after the sample recruiting | 
| Detection of candidate biomarkers in each participant using proteome detection or ELASA |  | The data is collected from lab in an average of 12 month after the sample recruiting | 
| 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 | These data is collected during follow-up visit after discharge |