A Registry Study on Genetics and Biomarkers of Acute Coronary Syndrome

Coronary Artery Disease Clinical Trial

— ARSGB-ACS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03752515
• Other study ID #: BeijingIHLBVD2018010
• Status: Active, not recruiting
• Start date: June 2, 2015
• Est. completion date: October 1, 2025

Study information

• Verified date: October 2023
• Source: Beijing Institute of Heart, Lung and Blood Vessel Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2000
• Est. completion date: October 1, 2025
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Myocardial Infarction
• Angina, Unstable
• Coronary Artery Disease
• Infarction
• Myocardial Infarction
• Syndrome
• Unstable Angina

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital	Beijing
China	Beijing Luhe Hospital, Capital Medical University	Beijing
China	The First Affiliated Hospital of Dalian Medical University	Dalian
China	The Second Hospital of Dalian Medical University	Dalian
China	The First Hospital of Jilin University	Jilin
China	People's Hospital of Henan University	Zhengzhou

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Institute of Heart, Lung and Blood Vessel Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Weight for each participant	kg	These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Echocardiography	LVEF and so on	These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Primary	Medication at discharge		These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Primary	Genetic data	Exon sequencing data or genotypes of candidate SNPs	Sequencing will be carried out in an average of 3 months after sample recruiting
Primary	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
Primary	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
Primary	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
Primary	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