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ST-segment Elevation Myocardial InfarctionNCT02641262

Henan STEMI Registry

An observational study of ST-segment Elevation Myocardial Infarction, run by Henan Institute of Cardiovascular Epidemiology at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
5,479 participants
Where
1 siteChina
Study dates
Sep 2016to Sep 2019
How long will I take part?
1 Year
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: STEMI patients within 30 days of symptom onset

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhengzhou university People's Hospital

    Zhengzhou, Henan, 450000

Other trials in China

About this study

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

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.

Read the 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.

Keywords
Myocardial Infarction, Angioplasty, Balloon, Coronary, Drug Therapy
Medical subject headings
ST Elevation Myocardial Infarction, Myocardial Infarction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All causes mortality

    Measured: At discharge, an average of 10 days

Secondary outcomes (4)

  1. All causes mortality

    Measured: 30 days

  2. adverse cardiovascular and cerebrovascular events (MACCE, death, congestive heart failure, reinfarction and ischemic stroke)

    Measured: At discharge, an average of 10 days

  3. All causes mortality

    Measured: 6 months

  4. All causes mortality

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2015 (estimated)
  2. Study startSep 2016
  3. Primary completionAug 2018
  4. Study completionSep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
5,479 participants (actual)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT02641262
Sponsor's protocol ID
HenanICE201501
Status last verified
Aug 2022
First submitted
15 Dec 2015
Last updated
5 Aug 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • Wang S, Zhang Y, Yang W, Wang X, Zhu Z, Qi D, Zhang J, Zhang J, Gao C. Impact of stress hyperglycemia ratio on incidence of in-hospital cardiogenic shock in patients with ST-elevation myocardial infarction: a prospective, multicenter study. Front Endocrinol (Lausanne). 2025 Dec 12;16:1677084. doi: 10.3389/fendo.2025.1677084. eCollection 2025.

    PubMed 41458546

  • Wang S, Zhang Y, Qi D, Wang X, Zhu Z, Yang W, Li M, Hu D, Gao C. Development and validation of a risk score for predicting 30-day mortality in patients with ST elevation myocardial infarction. Sci Rep. 2025 Mar 15;15(1):8930. doi: 10.1038/s41598-025-92615-3.

    PubMed 40087520

  • 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.

    PubMed 34930741

  • 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.

    PubMed 31783791

Questions about this trial

What is this clinical trial studying?

An observational study of ST-segment Elevation Myocardial Infarction, run by Henan Institute of Cardiovascular Epidemiology at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All causes mortality (time frame: At discharge, an average of 10 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02641262, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.

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