Acute Coronary Syndrome Genetic Study
Comprehensive Intervention and Outcome Research Programs for Acute Coronary Syndrome
1 other identifier
observational
3,422
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 14, 2013
CompletedFirst Posted
Study publicly available on registry
October 17, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJune 21, 2016
June 1, 2016
4.4 years
October 14, 2013
June 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Major adverse cardiovascular events
Death, Myocardial infarction, stroke, coronary revascularization
2 year
Study Arms (1)
ACS cohort
Patients diagnosed with acute coronary syndrome.
Eligibility Criteria
Patients from 75 hospitals in China.
You may qualify if:
- 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:
- 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
- Lack of persistent ST-segment elevation, LBBB or intraventricular conduction disturbances 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 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
- +3 more criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University First hospital
Beijing, Beijing Municipality, 100034, China
Biospecimen
4ml of vein blood are to be retained for genetic analysis.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Department of Cardiology
Study Record Dates
First Submitted
October 14, 2013
First Posted
October 17, 2013
Study Start
July 1, 2012
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
June 21, 2016
Record last verified: 2016-06