NCT03821012

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
8.1 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 29, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

January 29, 2019

Status Verified

January 1, 2019

Enrollment Period

10.9 years

First QC Date

January 22, 2019

Last Update Submit

January 28, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • the total duration of myocardial ischemia

    Median time from symptom onset to target vessel open in STEMI patients

    12 hours

  • the reperfusion treatment ratio

    the ratio of primary PCI plus thrombolysis usage in STEMI patients

    12 hours

Study Arms (3)

CSCAP-1

STEMI with symptom onset within 12 h regardless of whether receiving reperfusion or symptom onset within 12-24 h of needing PPCI

Other: in-hospital process optimization

CSCAP-2

STEMI patients with symptom onset within 30 days

Other: PPCI hospital-based regional STEMI transfer network construction

CSCAP-3

STEMI patients with symptom onset within 30 days

Other: the whole-city STEMI care network construction

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In CSCAP-1, a total of 4191 patients admitted to hospitals, with symptom onset within 12 h, regardless of whether receiving reperfusion or symptom onset within 12-24 h of needing PPCI, were enrolled consecutively in 53 tertiary hospitals qualified for PPCI in 14 provinces/municipalities/autonomous regions of China in 2012. In CSCAP-2, a total of 20,799 patients with STEMI occurrence within 30 days, regardless of reperfusion, were enrolled consecutively from PPCI hospitals 3 times at a 6-month interval in 244 PCI hospitals with hundreds of adjunct non-PCI hospitals from 24 provinces/municipalities/autonomous regions from 2015 to 2018. In CSCAP-3, a total of 30 hospitalized patients with symptom onset within 30 days were enrolled consecutively from each hospital every 3 months. Patients with STEMI were enrolled consecutively from the whole network units, including both PCI and non-PCI hospitals in 7 cities in China.

You may qualify if:

  • STEMI patients

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Related Publications (1)

  • Zhang Y, Yu B, Han Y, Wang J, Yang L, Wan Z, Zhang Z, Chen Y, Fu X, Gao C, Li B, Chen J, Wu M, Ma Y, Zhao X, Chen Y, Yan H, Xiang D, Fang W, Mehta S, Naber CK, Ge J, Huo Y. Protocol of the China ST-segment elevation myocardial infarction (STEMI) Care Project (CSCAP): a 10-year project to improve quality of care by building up a regional STEMI care network. BMJ Open. 2019 Jul 17;9(7):e026362. doi: 10.1136/bmjopen-2018-026362.

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Central Study Contacts

Yan Zhang, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Department of Cardiology

Study Record Dates

First Submitted

January 22, 2019

First Posted

January 29, 2019

Study Start

January 1, 2011

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

January 29, 2019

Record last verified: 2019-01

Locations