Clinical trial NCT02641262: Henan STEMI Registry
Official title: Henan ST-segment Elevation Myocardial Infarction (STEMI) Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ST-segment Elevation Myocardial Infarction
Keywords: Myocardial Infarction
Angioplasty, Balloon, Coronary
Drug Therapy
Lead sponsor: Henan Institute of Cardiovascular Epidemiology
Sponsor class: OTHER
First posted: 2015-12-29
Enrollment: 5479
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: STEMI patients within 30 days of symptom onset

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.

Eligibility criteria: 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.

Primary outcomes:
measure: All causes mortality
timeFrame: At discharge, an average of 10 days
Secondary outcomes:
measure: All causes mortality
timeFrame: 30 days
measure: adverse cardiovascular and cerebrovascular events (MACCE, death, congestive heart failure, reinfarction and ischemic stroke)
timeFrame: At discharge, an average of 10 days
measure: All causes mortality
timeFrame: 6 months
measure: All causes mortality
timeFrame: 1 year
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Zhengzhou university People's Hospital
state: Henan
Study officials:
affiliation: Henan Institute of Cardiovascular Epidemiology
name: Chuanyu Gao, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Henan Institute of Cardiovascular Epidemiology
name: Dayi Hu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang Y, Wang S, Cheng Q, Zhang J, Qi D, Wang X, Zhu Z, Li M, Hu D, Gao C; Henan STEMI registry Study Group. Reperfusion strategy and in-hospital outcomes for ST elevation myocardial infarction in secondary and tertiary hospitals in predominantly rural central China: a multicentre, prospective and observational study. BMJ Open. 2021 Dec 20;11(12):e053510. doi: 10.1136/bmjopen-2021-053510.
citation: Zhang Y, Wang S, Yang S, Yin S, Cheng Q, Li M, Qi D, Wang X, Zhu Z, Zhao L, Hu D, Gao C. Rationale and design of the Henan ST elevation myocardial infarction (STEMI) registry: a regional STEMI project in predominantly rural central China. BMC Cardiovasc Disord. 2019 Nov 28;19(1):271. doi: 10.1186/s12872-019-1250-9.