ST-Elevation Myocardial InfarctionNCT03821012
China STEMI Care Project
An observational study of ST-Elevation Myocardial Infarction, run by Peking University First Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST-Elevation Myocardial Infarction
- What is being tested?
- in-hospital process optimization, PPCI hospital-based regional STEMI transfer network construction and the whole-city STEMI care network construction
- How many people
- 50,000 participants
- Where
- 1 siteChina
- Study dates
- Jan 2011to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- STEMI patients
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Yan Zhang, MD
About this study
Official title: China STEMI Care Project: a 10-year Project to Improve Quality of Care by Building up the a Regional STEMI Care Network
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.
- Conditions
- ST-Elevation Myocardial Infarction
- Being tested
- in-hospital process optimization, PPCI hospital-based regional STEMI transfer network construction, the whole-city STEMI care network construction
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
in-hospital process optimizationOther
PPCI hospital-based regional STEMI transfer network constructionOther
the whole-city STEMI care network constructionOther
| Study group | Role | What they receive |
|---|---|---|
| CSCAP-1 | STEMI with symptom onset within 12 h regardless of whether receiving reperfusion or symptom onset within 12-24 h of needing PPCI Receives: Other: in-hospital process optimization | |
| CSCAP-2 | STEMI patients with symptom onset within 30 days Receives: Other: PPCI hospital-based regional STEMI transfer network construction | |
| CSCAP-3 | STEMI patients with symptom onset within 30 days Receives: Other: the whole-city STEMI care network construction |
What is being measured
The primary outcome is the main question the study is designed to answer.
the total duration of myocardial ischemia
Median time from symptom onset to target vessel open in STEMI patients
Measured: 12 hours
the reperfusion treatment ratio
the ratio of primary PCI plus thrombolysis usage in STEMI patients
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study startJan 2011
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ST-Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong Huo, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03821012
- Sponsor's protocol ID
- CSCAP
- Status last verified
- Jan 2019
- First submitted
- 22 Jan 2019
- Last updated
- 29 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31320346
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China STEMI Care Project: a 10-year Project to Improve Quality of Care by Building up the a Regional STEMI Care Network
- ClinicalTrials.gov ID
- NCT03821012
- Acronym / sponsor ID
- CSCAP
- Conditions
- ST-Elevation Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- Jan 2011 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 29 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CSCAP-1 | – | Other: in-hospital process optimizationSTEMI with symptom onset within 12 h regardless of whether receiving reperfusion or symptom onset within 12-24 h of needing PPCI |
| CSCAP-2 | – | Other: PPCI hospital-based regional STEMI transfer network constructionSTEMI patients with symptom onset within 30 days |
| CSCAP-3 | – | Other: the whole-city STEMI care network constructionSTEMI patients with symptom onset within 30 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- STEMI patients
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| in-hospital process optimization | Other | CSCAP-1 |
| PPCI hospital-based regional STEMI transfer network construction | Other | CSCAP-2 |
| the whole-city STEMI care network construction | Other | CSCAP-3 |
Primary outcome
the total duration of myocardial ischemia
Time frame: 12 hours
Median time from symptom onset to target vessel open in STEMI patients
the reperfusion treatment ratio
Time frame: 12 hours
the ratio of primary PCI plus thrombolysis usage in STEMI patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
- Derived from this study: PubMed 31320346Zhang 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.
Related trials for ST-Elevation Myocardial Infarction
RecruitingObservational study
SuperSaturated Oxygen Comprehensive Observational Registry
STEMI - ST Elevation Myocardial Infarction, AMI
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Not yet recruitingPhase 2
Evaluating SGLT2 Inhibitors for the Reduction of No-Reflow Phenomenon in Patients Undergoing PCI
No Reflow Phenomenon, Reperfusion Injuries, Myocardial
Recruiting
Reducing Slow/No-Reflow With Prophylactic High-Dose Intracoronary Adenosine Protocol in ST-Elevation Myocardial Infarction The REFLOW AMI Trial
ST-Elevation Myocardial Infarction (STEMI)
RecruitingObservational study
Breisgau PHENO-HEART MI
Myocardial Infarction, STEMI
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ST-Elevation Myocardial Infarction, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Zhang, MD (8610-83575728, drzhy1108@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the total duration of myocardial ischemia (time frame: 12 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03821012, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2019.