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A Registry Study on Genetics and Biomarkers of Acute Coronary Syndrome

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03752515
Acronym
ARSGB-ACS
Enrollment
2000
Registered
2018-11-26
Start date
2015-06-02
Completion date
2025-10-01
Last updated
2023-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

Interventions

None listed

Sponsors

Beijing Institute of Heart, Lung and Blood Vessel Diseases
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Age for each participantThese data is collected from the cases' medical record in an average of 1 month after the sample recruitingcurrent age and onset age
Gender for each participantThese data is collected from the cases' medical record in an average of 1 month after the sample recruitingmale or female
Height for each participantThese data is collected from the cases' medical record in an average of 1 month after the sample recruitingcm cm cm
Weight for each participantThese data is collected from the cases' medical record in an average of 1 month after the sample recruitingkg
Contact information for each participantThese data is collected from the cases' medical record in an average of 1 month after the sample recruitingtelephone
Past Medical HistoryThese data is collected from the cases' medical record in an average of 1 month after the sample recruitingincluding disease history, surgical history, and medical history
LifestyleThese data is collected from the cases' medical record in an average of 1 month after the sample recruitingincluding smoking history and drinking, specify how many years smoking or drinking lasted and detail quantity per day
BiochemicalThese data is collected from the cases' medical record in an average of 1 month after the sample recruitingincluding blood lipid, fasting glucose, Creatinine and so on
BiomarkersThese data is collected from the cases' medical record in an average of 1 month after the sample recruitingincluding cTnI, BNP, hs-CRP, and so on
Overall lesion profilesThese data is collected from the cases' medical record in an average of 1 month after the sample recruitinghow many vessels involved
EchocardiographyThese data is collected from the cases' medical record in an average of 1 month after the sample recruitingLVEF and so on
Medication at dischargeThese data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Genetic dataSequencing will be carried out in an average of 3 months after sample recruitingExon sequencing data or genotypes of candidate SNPs
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 recruitingThe 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.
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 recruitingRelative 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 ELASAThe 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.These data is collected during follow-up visit after dischargeHF includes in-hospital and long-term post-discharge HF incidence

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026