China STEMI Care Project Phase 2

• Conditions: ST-Elevation Myocardial Infarction
• Interventions: Other: clinical pathway

• Registration Number: NCT03011879
• Lead Sponsor: Peking University First Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2016-08-27
• Status Verified: 2017-01
• Study First Submitted QC: 2017-01-04
• Last Update Submitted: 2017-01-04
• Study First Posted: 2017-01-05
• Last Update Posted: 2017-01-05
• Primary Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 18000

Inclusion Criteria

• STEMI patients with symptom onset within 30 days

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
3.STEMI patients with symptom onset within 30 days	clinical pathway	Third round enrollment of STEMI patients with symptom onset within 30 days
1.STEMI patients with symptom onset within 30 days	clinical pathway	First round enrollment of STEMI patients with symptom onset within 30 days
2.STEMI patients with symptom onset within 30 days	clinical pathway	Second round enrollment of STEMI patients with symptom onset within 30 days

Primary Outcome Measures

Name	Time	Method
Usage of both DAPT, statin, β blocker and ACEI/ARB in patients without contraindication	3 yeras	DAPT means dual antiplatelet therapy
Hospital admission via ambulance ratio	2 years
Bypass ED ratio in patients with symptom onset within 12 hours	12 hours
Door-to-ballnoon time in patients with symptom onset within 12 hours	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	12 hours	Door-to-needle time is the key index to evaluate treatment of thrombolysis
Symptom onset to arrive in hospital	2 years
1-year on time follow-up ratio	1 year
In-hospital morbidity	2 yeras
Referfusion ratio in patients with symptom onset within 12 hours	12 hours	Referfusion including primary PCI and thrombolysis is the key strategy in STEMI care

Trial Locations

Locations (1)

Department of Cardiology, Peking University First Hospital; 🇨🇳 Beijing, China