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Acute Coronary Syndrome Genetic Study

Comprehensive Intervention and Outcome Research Programs for Acute Coronary Syndrome

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01964313
Enrollment
3422
Registered
2013-10-17
Start date
2012-07-31
Completion date
2016-12-31
Last updated
2016-06-21

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

Conditions

Acute Coronary Syndrome

Keywords

Acute coronary syndrome, treatment strategy, genetics

Brief summary

To describe the role of genetic factors and its relationship and interaction with environmental factors in the recurrence of cardiac events in Chinese patients with acute coronary syndrome.

Detailed description

* Research cohort: Patients diagnosed with acute coronary syndrome are enrolled and to be followed up for 2 years. * Baseline and follow up variables include patients' demographics, medical history, ACS event characteristics, clinical treatment options (interventional cardiology, drug therapy: antithrombotic therapy, other treatments recommended by guidelines ) and follow up events information. * Blood Sample collection 4ml of vein blood will be drawed. Centrifugation of plasma and WBC will be done on-site within 30 minutes for DNA extraction. Samples will be stored at -80℃ freezer for subsequent applications. * A nested case-controlled study is designed for the genetic analysis: 1. Cases: Patients suffered from death, myocardial infarction, stroke and coronary revascularization and bleeding during the 2-year follow up. We expected to get 600 cases in the study cohort; 2. Controls: among patients without any of the above events during follow, matched controls of 1:1 ratio will be selected according to date of admission (± 1 month), age (± 5 years), sex, baseline ACS diagnosis, whether treated with PCI , the same pattern of antithrombotic therapy and the study center. * Genotyping Genotype testing using exome DNA chips (Exome Beadchip). Exome Beadchip is a high-throughput DNA chip designed by Illumina's, containing 240,000 SNP on exons in the genome that may lead to functional changes. * Analysis: 1. To analysis the impact of genetic characteristics on selection of treatment strategy in ACS patients, and its interaction with other baseline clinical variables. 2. To analysis the impact of genetic characteristics on patient outcomes, and its interaction with clinical characteristics and management patterns.

Interventions

None listed

Sponsors

Ministry of Science and Technology of the People´s Republic of China
CollaboratorOTHER_GOV
Peking University First Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Written informed consent has been provided. * Contact Order Form has been provided. * Aged 18 years or older. * 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. * Hospitalized within 48 hours of onset of symptoms.

Exclusion criteria

Patients will not be eligible to participate if any of the following

Design outcomes

Primary

MeasureTime frameDescription
Major adverse cardiovascular events2 yearDeath, Myocardial infarction, stroke, coronary revascularization

Countries

China

Contacts

Primary ContactJie Jiang, MD
jiangjie@medmail.com.cn8610-83575180
Backup ContactXiaolan Zhou
zhouxiaolan@clevel.cn8610-83575262

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026