Clinical Trial: Acute Coronary Syndrome Genetic Study
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Comprehensive Intervention and Outcome Research Programs for Acute Coronary Syndrome
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 Summary:
- 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.
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A nested case-controlled study is designed for the genetic analysis:
- 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;
- 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.
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Analysis:
- To analysis the impact o
Sponsor: Peking University First Hospital
Current Primary Outcome: Major adverse cardiovascular events [ Time Frame: 2 year ]
Death, Myocardial infarction, stroke, coronary revascularization
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Peking University First Hospital
Dates:
Date Received: October 14, 2013
Date Started: July 2012
Date Completion: December 2016
Last Updated: June 20, 2016
Last Verified: June 2016
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