Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02641262 |
| Other study ID # |
HenanICE201501 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 2016 |
| Est. completion date |
September 2019 |
Study information
| Verified date |
August 2022 |
| Source |
Henan Institute of Cardiovascular Epidemiology |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
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.
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.
