Trials / Unknown
UnknownNCT01964313
Acute Coronary Syndrome Genetic Study
Comprehensive Intervention and Outcome Research Programs for Acute Coronary Syndrome
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 3,422 (estimated)
- Sponsor
- Peking University First Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2012-07-01
- Primary completion
- 2016-12-01
- Completion
- 2016-12-01
- First posted
- 2013-10-17
- Last updated
- 2016-06-21
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT01964313. Inclusion in this directory is not an endorsement.