China STEMI Care Project Phase 2

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 Overview

• Status: Unknown
• Conditions: ST-Elevation Myocardial Infarction
• Intervention / Treatment: Other: clinical pathway

• Study Type: Observational
• Enrollment (Anticipated): 18000

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100034
    • Recruiting
    • Department of Cardiology, Peking University First Hospital
    • Contact: Yan Zhang, MD; Phone Number: 8610-83575728; Email: drzhy1108@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

STEMI patients with symptom onset within 30 days

Description

Inclusion Criteria:

• STEMI patients with symptom onset within 30 days

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1.STEMI patients with symptom onset within 30 days; First round enrollment of STEMI patients with symptom onset within 30 days	Other: clinical pathway
2.STEMI patients with symptom onset within 30 days; Second round enrollment of STEMI patients with symptom onset within 30 days	Other: clinical pathway
3.STEMI patients with symptom onset within 30 days; Third round enrollment of STEMI patients with symptom onset within 30 days	Other: clinical pathway

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking University First Hospital
• Collaborators: Chinese Medical Doctor Association

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Anticipated): December 1, 2017
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: August 27, 2016
• First Submitted That Met QC Criteria: January 4, 2017
• First Posted (Estimate): January 5, 2017

Study Record Updates

• Last Update Posted (Estimate): January 5, 2017
• Last Update Submitted That Met QC Criteria: January 4, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction
• Other Study ID Numbers: CSCAP-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No