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Clinical Trials/NCT03011879
NCT03011879UnknownNot Applicable

China STEMI Care Project Phase 2

Peking University First Hospital1 site in 1 country18,000 target enrollmentStarted: July 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
18,000
Locations
1
Primary Endpoint
Usage of both DAPT, statin, β blocker and ACEI/ARB in patients without contraindication

Study Overview

Brief Summary

The program is to improve STEMI medical care quality in China. With the documents issued by National Health and Family Planning Commission of the People's Republic of China, the program was initialed in at least 200 primary PCI capable hospitals together with hundreds of adjacent non-primary PCI capable hospitals in 15 provinces. STEMI patients with symptom onset within 30 days will be enrolled in 3 periods. In each period with 6-month interval, 30 patients will be enrolled consecutively from each PCI-capable center initially and from non-primary PCI capable hospitals later, thus at least 18,000 STEMI patients from primary PCI capable hospitals will be enrolled and all of them will be followed up for 1 year. Key performance indicators (KPIs) in STEMI care will be collected using both national PCI online registry and a program STEMI online registry database for the purpose of improvement of medical care. Hospital KPIs rank report and problem-based resolution will be feedback to each hospital after data analysis in each period. Comparison of every two cross-sectional data (self) and within one cross-sectional (inter-hospital) data will be used to evaluate the improvement of medical quality.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • STEMI patients with symptom onset within 30 days

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Usage of both DAPT, statin, β blocker and ACEI/ARB in patients without contraindication

Time Frame: 3 yeras

DAPT means dual antiplatelet therapy

Hospital admission via ambulance ratio

Time Frame: 2 years

Bypass ED ratio in patients with symptom onset within 12 hours

Time Frame: 12 hours

Door-to-ballnoon time in patients with symptom onset within 12 hours

Time Frame: 12 hours

Door-to-ballnoon time is the key index to evaluate treatment of primary PCI

Door-to-needle time in patients with symptom onset within 12 hours

Time Frame: 12 hours

Door-to-needle time is the key index to evaluate treatment of thrombolysis

Symptom onset to arrive in hospital

Time Frame: 2 years

1-year on time follow-up ratio

Time Frame: 1 year

In-hospital morbidity

Time Frame: 2 yeras

Referfusion ratio in patients with symptom onset within 12 hours

Time Frame: 12 hours

Referfusion including primary PCI and thrombolysis is the key strategy in STEMI care

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yong Huo

Director, Department of Cardiology

Peking University First Hospital

Study Sites (1)

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