Henan STEMI Registry

Completed

• Conditions: ST-segment Elevation Myocardial Infarction

• Registration Number: NCT02641262
• Lead Sponsor: Henan Institute of Cardiovascular Epidemiology

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-12-15
• Study First Submitted QC: 2015-12-22
• Study First Posted: 2015-12-29
• Study Start: 2016-09
• Primary Completion: 2018-08
• Study Completion: 2019-09
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-03
• Last Update Posted: 2022-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5479

Inclusion Criteria

• 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.

Exclusion Criteria

• percutaneous coronary intervention (PCI)-related myocardial infarction or coronary artery bypass graft (CABG)-related myocardial infarction.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All causes mortality	At discharge, an average of 10 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Zhengzhou university People's Hospital; 🇨🇳 Zhengzhou, Henan, China