A Registry Study on Genetics and Biomarkers of Acute Coronary Syndrome

NCT03752515 | Unknown DMC

• 1 other identifier: BeijingIHLBVD2018010
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (17)

• 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

Study Arms (3)

case-ACS-MACE

ACS patients with poor prognosis

control-ACS-MACE

ACS patients with good prognosis

Health-control

general population without ACS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Case-ACS-MACE group consists of patients who was diagnosed as Acute Coronary Syndrome and had a poor prognosis during follow up. Control-ACS-MACE group consists of patients who was diagnosed as Acute Coronary Syndrome and had a good prognosis during follow up. Health control group is general population without Acute Coronary Syndrome.

You may qualify if:

• 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:
• 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.
• Criteria for NSTEMI diagnosis:
• 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.

You may not qualify if:

• 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.
• Age and gender are matched with cases.
• No Coronary Artery Disease was detected by Coronary CT examination.
• Normal biochemical indicators.

Sponsors & Collaborators

• Beijing Institute of Heart, Lung and Blood Vessel Diseases: lead

Study Sites (6)

Beijing Anzhen Hospital

Beijing, 100029, China

Location

Beijing Luhe Hospital, Capital Medical University

Beijing, China

Location

The First Affiliated Hospital of Dalian Medical University

Dalian, China

Location

The Second Hospital of Dalian Medical University

Dalian, China

Location

The First Hospital of Jilin University

Jilin, China

Location

People's Hospital of Henan University

Zhengzhou, China

Location

Related Publications (2)

• Ma J, Ma K, Chen J, Yang X, Gao F, Gao H, Zhang H, Ma XL, Du J, Li P, Li Y. Development and Validation of Risk Stratification for Heart Failure After Acute Coronary Syndrome Based on Dynamic S100A8/A9 Levels. J Am Heart Assoc. 2025 Feb 4;14(3):e037401. doi: 10.1161/JAHA.124.037401. Epub 2025 Feb 3.

  PMID: 39895550 DERIVED

• Li Y, Chen B, Yang X, Zhang C, Jiao Y, Li P, Liu Y, Li Z, Qiao B, Bond Lau W, Ma XL, Du J. S100a8/a9 Signaling Causes Mitochondrial Dysfunction and Cardiomyocyte Death in Response to Ischemic/Reperfusion Injury. Circulation. 2019 Aug 27;140(9):751-764. doi: 10.1161/CIRCULATIONAHA.118.039262. Epub 2019 Jun 21.

  PMID: 31220942 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

If a blood specimen is obtained, it will be separated and stored at -80 ℃ as plasma, viable cells, and extracted DNA. If a saliva specimen is obtained, it is stored for DNA. If a tissue specimen is obtained, it will be cut into small pieces and stored at liquid nitrogen.

MeSH Terms

Conditions

Coronary Artery Disease; Acute Coronary Syndrome; Angina, Unstable

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jie Du, PHD

  Beijing Anzhen Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 26, 2018
• Study Start: June 2, 2015
• Primary Completion: June 1, 2021
• Study Completion: October 1, 2025
• Last Updated: October 26, 2023

Record last verified: 2023-10

Locations

CN (6)