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China STEMI Care Project

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ClinicalTrials.gov Identifier: NCT03821012
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Yong Huo, Peking University First Hospital

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.


Condition or disease Intervention/treatment
ST-Elevation Myocardial Infarction Other: in-hospital process optimization Other: PPCI hospital-based regional STEMI transfer network construction Other: the whole-city STEMI care network construction

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Study Type : Observational
Estimated Enrollment : 50000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: China STEMI Care Project: a 10-year Project to Improve Quality of Care by Building up the a Regional STEMI Care Network
Actual Study Start Date : January 2011
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. the total duration of myocardial ischemia [ Time Frame: 12 hours ]
    Median time from symptom onset to target vessel open in STEMI patients

  2. the reperfusion treatment ratio [ Time Frame: 12 hours ]
    the ratio of primary PCI plus thrombolysis usage in STEMI patients



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.

Criteria

Inclusion Criteria:

  • STEMI patients

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821012


Contacts
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Contact: Yan Zhang, MD 8610-83575728 drzhy1108@163.com

Locations
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China, Beijing
Peking University First Hospital Recruiting
Beijing, Beijing, China, 100034
Contact: Yan Zhang, MD         
Sponsors and Collaborators
Peking University First Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yong Huo, Director, Department of Cardiology, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT03821012    
Other Study ID Numbers: CSCAP
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases