China STEMI Care Project

ST-Elevation Myocardial Infarction Clinical Trial

Official title:

China STEMI Care Project: a 10-year Project to Improve Quality of Care by Building up the a Regional STEMI Care Network

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03821012
• Other study ID #: CSCAP
• Status: Recruiting
• Start date: January 2011
• Est. completion date: December 2021

Study information

• Verified date: January 2019
• Source: Peking University First Hospital
• Contact: Yan Zhang, MD
• Phone: 8610-83575728
• Email: drzhy1108[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The China ST-elevation myocardial infarction (STEMI) Care Project (CSCAP) aims to improve the reperfusion treatment rate and shorten the total duration of myocardial ischemia by establishing a regional STEMI treatment network covering the whole-city region, whole-city population, and whole-disease process step by step. The CSCAP is a prospective, multicenter registry involving three phases. A total of 18 provinces, 4 municipalities, and 2 autonomous regions in China were included. Patients with STEMI who met with the third acute myocardial infarction definition and the Chinese STEMI diagnosis and treatment guidelines were enrolled and the estimated number is over 50,000. Phase 1 (CSCAP-1) focused on the in-hospital process optimization of primary percutaneous coronary intervention (PPCI) hospitals. Phase 2 (CSCAP-2) focused on the PPCI hospital-based regional STEMI transfer network, including emergency medical services and non-PPCI hospitals. Phase 3 (CSCAP-3) focused on the whole-city STEMI care network construction by promoting chest pain center accreditation. Systematic data collection, assessment of quality of care, and subsequent improvement were implemented throughout the project to continuously improve the quality of care for patients with STEMI.

CSCAP is the first project that focused on establishing a regional STEMI emergency care network in China to help understand the condition of STEMI care in China extensively. Moreover, its objective was to optimize the quality of STEMI care through in-hospital process optimization (2012-2013), PPCI hospital-based regional STEMI transfer network construction (2015-2018), and construction of the whole-city STEMI care network step by step (2018-2021). However, hospitals were not randomly selected in CSCAP, which might be because of the lack of representatives to some degree. Alternatively, it focused on providing a tailored quality-of-care improvement plan based on the conditions of different regions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50000
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• STEMI patients

Exclusion Criteria:

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• ST-Elevation Myocardial Infarction

Intervention

Other:
• in-hospital process optimization

• PPCI hospital-based regional STEMI transfer network construction

• the whole-city STEMI care network construction

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the total duration of myocardial ischemia	Median time from symptom onset to target vessel open in STEMI patients	12 hours
Primary	the reperfusion treatment ratio	the ratio of primary PCI plus thrombolysis usage in STEMI patients	12 hours