Henan ST-segment Elevation Myocardial Infarction (STEMI) Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5,479
- 试验地点
- 1
- 主要终点
- All causes mortality
研究概览
简要总结
ST-segment elevation myocardial infarction (STEMI) remains among the most acute and critical diseases, with primary percutaneous coronary intervention (pPCI) and thrombolysis as mainstay reperfusion treatments. Real-world implementation of current guidelines for STEMI management has been assessed in developed countries and large Chinese cities. However, until now, there has been no registry on patients with STEMI in Henan, the most populated (about 100 million) and predominantly rural (66%) province in central China.
This registry is aimed to assess management practices, time delays, outcomes and reasons for not receiving reperfusion therapy in consecutive STEMI patients in reperfusion-capable hospitals, i.e., tertiary and secondary, in Henan province.
详细描述
- Henan institute of cardiovascular epidemiology is responsible for design, data quality control and statistical analysis.
- Data are collected using a uniformed questionnaire by trained staff at each hospital.
- Sample size estimation: Based on Henan retrospective observational cohort of STEMI patients, in-hospital mortality in secondary and tertiary hospitals were 5.6% and 6.0%, respectively. To achieve a precision of 20% with an α of 0.05 in each of the hospital, investigators need a sample of 5000, 2500 in each class hospital.
- Statistical analysis plan: Investigators will report summary statistics for patient characteristics, delay time (symptom onset-to-first medical contact(FMC), FMC-to-reperfusion), patient referral (time and means of transportation), treatments received and primary outcomes. Investigators will also undertake the following prespecified subgroup analyses: hospital class, age, sex, killip class, time to first medical contact, infarct location, history of hypertension, diabetes or smoking and thrombolysis in myocardial infarction risk score.
- Quality assurance plan
1)Diagnosis of STEMI is according to the third universal definition of myocardial infarction.
2)Before registry, a training program on study objectives, data collection, and STEMI management is given to the primary investigator and related staff at each participating center.
3)Henan institute of cardiovascular epidemiology will regularly monitored at least 10% of questionnaires for accuracy against medical records. If the questionnaires are not completed with 98% accuracy, all questionnaires are considered unqualified and this staff will be retrained.
4)Real-time automatic logic and range check on the completeness and validity of the data are integrated in the data entry system to control basic data quality. Henan ICE regularly provides data quality checks and sends queries for illogical, invalid or missing data elements to participating hospitals to review and revise. Participating centres who has the high error rate of data, and no change in 6 months shall be deemed abandoned automatically; participating centres who has the high quality of data will be issued a certificate to reward.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •STEMI is defined in accordance with the universal definition of myocardial infarction, specifically as persistent ST-segment elevation (≥0.1 millivolt at J points) in 2 or more contiguous leads.
排除标准
- •percutaneous coronary intervention (PCI)-related myocardial infarction or coronary artery bypass graft (CABG)-related myocardial infarction.
结局指标
主要结局
All causes mortality
时间窗: At discharge, an average of 10 days
次要结局
- All causes mortality(1 year)
- adverse cardiovascular and cerebrovascular events (MACCE, death, congestive heart failure, reinfarction and ischemic stroke)(At discharge, an average of 10 days)
研究者
Chuanyu Gao
Director
Henan Institute of Cardiovascular Epidemiology