Henan STEMI Registry

ST-segment Elevation Myocardial Infarction Clinical Trial

Official title: Henan ST-segment Elevation Myocardial Infarction (STEMI) Registry

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

1. Henan institute of cardiovascular epidemiology is responsible for design, data quality control and statistical analysis.

2. Data are collected using a uniformed questionnaire by trained staff at each hospital.

3. 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.

4. 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.

5. 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.

5)Investigator meeting will be annually held to conclude the progress, solve existing problems and strengthen program training. ;

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• ST-segment Elevation Myocardial Infarction

• NCT number: NCT02641262
• Study type: Observational [Patient Registry]
• Source: Henan Institute of Cardiovascular Epidemiology
• Status: Completed
• Start date: September 2016
• Completion date: September 2019