A Chinese Registry to Determine the Genetics Risk Factors and Serumal Biomarkers for Acute Coronary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,000
- 试验地点
- 6
- 主要终点
- Age for each participant
研究概览
简要总结
This is a national registry study to determine genetics risk factors and serial biomarkers of Acute Coronary Syndrome.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Age for each participant
时间窗: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
current age and onset age
Contact information for each participant
时间窗: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
telephone
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.
时间窗: These data is collected during follow-up visit after discharge
HF includes in-hospital and long-term post-discharge HF incidence
Gender for each participant
时间窗: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
male or female
Height for each participant
时间窗: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
cm cm cm
Weight for each participant
时间窗: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
kg
Lifestyle
时间窗: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
including smoking history and drinking, specify how many years smoking or drinking lasted and detail quantity per day
Biochemical
时间窗: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
including blood lipid, fasting glucose, Creatinine and so on
Overall lesion profiles
时间窗: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
how many vessels involved
Medication at discharge
时间窗: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Past Medical History
时间窗: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
including disease history, surgical history, and medical history
Echocardiography
时间窗: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
LVEF and so on
Metabolomic profile on Liquid Chromatograph Mass Spectrometer/Mass Spectrometer analysis of serum sample.
时间窗: The data is collected from lab in an average of 3 month after the sample recruiting
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.
Biomarkers
时间窗: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
including cTnI, BNP, hs-CRP, and so on
Genetic data
时间窗: Sequencing will be carried out in an average of 3 months after sample recruiting
Exon sequencing data or genotypes of candidate SNPs
Detection of miRNAs expression in each participant using the qRT-PCT method.
时间窗: The data is collected from lab in an average of 3 month after the sample recruiting
Relative expression levels of miRNA were analyzed using the 2-△Ct method and U6 was used as an endogenous control.
Detection of candidate biomarkers in each participant using proteome detection or ELASA
时间窗: The data is collected from lab in an average of 12 month after the sample recruiting
次要结局
未报告次要终点