A Registry Study on Genetics and Biomarkers of Acute Coronary Syndrome

Active, not recruiting

• Conditions: Coronary Artery Disease; Acute Coronary Syndrome; Acute Myocardial Infarction; Unstable Angina

• Registration Number: NCT03752515
• Lead Sponsor: Beijing Institute of Heart, Lung and Blood Vessel Diseases

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-02
• Study First Submitted: 2018-10-31
• Study First Submitted QC: 2018-11-21
• Study First Posted: 2018-11-26
• Primary Completion: 2021-06-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-24
• Last Update Posted: 2023-10-26
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Age for each participant	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	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.	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	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	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	These data is collected from the cases' medical record in an average of 1 month after the sample recruiting	kg
Lifestyle	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	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	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	These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Past Medical History	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	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.	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	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	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.	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	The data is collected from lab in an average of 12 month after the sample recruiting

Trial Locations

Locations (6)

People's Hospital of Henan University; 🇨🇳 Zhengzhou, China

Beijing Anzhen Hospital; 🇨🇳 Beijing, China

The Second Hospital of Dalian Medical University; 🇨🇳 Dalian, China

Beijing Luhe Hospital, Capital Medical University; 🇨🇳 Beijing, China

The First Affiliated Hospital of Dalian Medical University; 🇨🇳 Dalian, China

The First Hospital of Jilin University; 🇨🇳 Jilin, China