ST-Elevation Myocardial InfarctionNCT03011879
China STEMI Care Project Phase 2
An observational study of ST-Elevation Myocardial Infarction, run by Peking University First Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ST-Elevation Myocardial Infarction
- What is being tested?
- clinical pathway
- How many people
- 18,000 participants
- Where
- 1 siteChina
- Study dates
- Jul 2015to Dec 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: STEMI patients with symptom onset within 30 days
Who may be able to join
- STEMI patients with symptom onset within 30 days
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Cardiology, Peking University First Hospital
Beijing, 100034
Yan Zhang, MD, 8610-83575728, drzhy1108@163.com
Yong Huo, MD
About this study
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.
- Conditions
- ST-Elevation Myocardial Infarction
- Being tested
- clinical pathway
- 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.
clinical pathwayOther
| Study group | Role | What they receive |
|---|---|---|
| 1.STEMI patients with symptom onset within 30 days | First round enrollment of STEMI patients with symptom onset within 30 days Receives: Other: clinical pathway | |
| 2.STEMI patients with symptom onset within 30 days | Second round enrollment of STEMI patients with symptom onset within 30 days Receives: Other: clinical pathway | |
| 3.STEMI patients with symptom onset within 30 days | Third round enrollment of STEMI patients with symptom onset within 30 days Receives: Other: clinical pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Referfusion ratio in patients with symptom onset within 12 hours
Referfusion including primary PCI and thrombolysis is the key strategy in STEMI care
Measured: 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
Measured: 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
Measured: 12 hours
Hospital admission via ambulance ratio
Measured: 2 years
Symptom onset to arrive in hospital
Measured: 2 years
Bypass ED ratio in patients with symptom onset within 12 hours
Measured: 12 hours
Usage of both DAPT, statin, β blocker and ACEI/ARB in patients without contraindication
DAPT means dual antiplatelet therapy
Measured: 3 yeras
In-hospital morbidity
Measured: 2 yeras
1-year on time follow-up ratio
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startJul 2015
- Primary completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 18,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Medical Doctor Association
- Responsible party
- Principal investigator, Yong Huo, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03011879
- Sponsor's protocol ID
- CSCAP-2
- Status last verified
- Jan 2017
- First submitted
- 27 Aug 2016
- Last updated
- 5 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China STEMI Care Project Phase 2
- ClinicalTrials.gov ID
- NCT03011879
- Acronym / sponsor ID
- CSCAP-2
- Conditions
- ST-Elevation Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 18,000 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- Chinese Medical Doctor Association
- Study start
- Jul 2015
- Primary completion
- Dec 2017 (estimated)
- First posted
- 5 Jan 2017 (estimated)
- 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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1.STEMI patients with symptom onset within 30 days | – | Other: clinical pathwayFirst round enrollment of STEMI patients with symptom onset within 30 days |
| 2.STEMI patients with symptom onset within 30 days | – | Other: clinical pathwaySecond round enrollment of STEMI patients with symptom onset within 30 days |
| 3.STEMI patients with symptom onset within 30 days | – | Other: clinical pathwayThird round enrollment of STEMI patients with symptom onset within 30 days |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- STEMI patients with symptom onset within 30 days
Key inclusion criteria (1 listed)
- STEMI patients with symptom onset within 30 days
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 |
|---|---|---|
| clinical pathway | Other | 1.STEMI patients with symptom onset within 30 days, 2.STEMI patients with symptom onset within 30 days, 3.STEMI patients with symptom onset within 30 days |
Primary outcome
Referfusion ratio in patients with symptom onset within 12 hours
Time frame: 12 hours
Referfusion including primary PCI and thrombolysis is the key strategy in STEMI care
Door-to-ballnoon time in patients with symptom onset within 12 hours
Time frame: 12 hours
Door-to-ballnoon time is the key index to evaluate treatment of primary PCI
Door-to-needle time in patients with symptom onset within 12 hours
Time frame: 12 hours
Door-to-needle time is the key index to evaluate treatment of thrombolysis
Hospital admission via ambulance ratio
Time frame: 2 years
Symptom onset to arrive in hospital
Time frame: 2 years
Bypass ED ratio in patients with symptom onset within 12 hours
Time frame: 12 hours
Usage of both DAPT, statin, β blocker and ACEI/ARB in patients without contraindication
Time frame: 3 yeras
DAPT means dual antiplatelet therapy
In-hospital morbidity
Time frame: 2 yeras
1-year on time follow-up ratio
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2017.
- Individual participant dataSharing planned: No
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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 5 Jan 2017. 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?
Referfusion ratio in patients with symptom onset within 12 hours (time frame: 12 hours). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2017.