ST Elevation Myocardial InfarctionNCT04088682
Clinical Performance and Quality Measures for Adults With Acute ST-Elevation Myocardial Infarction in China
An observational study of ST Elevation Myocardial Infarction, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
This study aims to investigate and evaluate clinical performance and quality measures for adults with acute ST-elevation myocardial infarction (STEMI) in China. Further more, the investigates like to develop quality improvement strategies and relevant tools focusing on treatment and clinical outcome in patients with… 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?
- Quality improvement strategies and tools
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200,000 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2018to 31 Dec 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients with STEMI who arrive at the hospital within 48 hours from the symptoms onset
Who may be able to join
- Patients with STEMI who arrive at the hospital within 48 hours from the symptoms onset.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Hongjian Wang
Beijing, Beijing Municipality, 100037
Hongjian Wang, 13910008985 ext. 13910008985, wanghongjianfw@hotmail.com
Yin Dong, 13552582795
About this study
This study aims to investigate and evaluate clinical performance and quality measures for adults with acute ST-elevation myocardial infarction (STEMI) in China. Further more, the investigates like to develop quality improvement strategies and relevant tools focusing on treatment and clinical outcome in patients with STEMI. This is a annually survey , through consecutively recruiting all eligible inpatients and collecting relevant medical information, the performance of all participating hospitals. Further, quality improvement strategies including summary of clinical performance and quality measures, clinical pathways and team building will be organized for the purpose of quality improvement. All hospitals will consecutively recruit qualified patients in the same method adopted in baseline period. Then the reperfusion rates and other performance measures will be compared annually.
Read the detailed description
Cardiovascular disease (CVD) is a major concern in public health globally, as well as in China, and remarkable variations of resources available and health system performance have been noted. Acute myocardial infarction is one of the leading causes of mortality and morbidity, both in rural and urban area.
This study aims to investigate and evaluate clinical performance and quality measures for adults with acute ST-elevation myocardial infarction (STEMI) in China. Further more, the investigates like to develop quality improvement strategies and relevant tools focusing on treatment and clinical outcome in patients with STEMI.
This is a annually survey , through consecutively recruiting all eligible inpatients and collecting relevant medical information, the performance of all participating hospitals. Demographic characteristics, clinical features, diagnostic tests, medications, procedures, and in-hospital outcomes of patients will be obtained and then, the treatment pattern and outcomes will be evaluated. Further, quality improvement strategies including summary of clinical performance and quality measures, clinical pathways and professional training will be organized for the purpose of quality improvement. All hospitals will consecutively recruit qualified patients in the same method adopted in baseline period. Then the reperfusion rates and other performance measures will be compared annually.
New knowledge will be generated about STEMI management in China, to improve STEMI patients prognosis in future.
- Conditions
- ST Elevation Myocardial Infarction
- Being tested
- Quality improvement strategies and tools
- Keywords
- clinical performance, quality measures, ST-Elevation myocardial infarction
- 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.
Quality improvement strategies and toolsBehavioural
Quality improvement strategies and tools
| Study group | Role | What they receive |
|---|---|---|
| All hospitals | All hospitals will take the treatment quality improvement strategies and tools into implementation.
Intervention: Behavioral: Quality improvement strategies and tools Receives: Behavioral: Quality improvement strategies and tools |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aspirin at arrival
Proportion of aspirin use within 24 hours of admission among eligible patients
Measured: 24 hours after admission
Clopidogrel (or ticagrelor) at arrival
Proportion of Clopidogrel (or ticagrelor) use within 24 hours of admission among eligible patients
Measured: 24 hours after admission
β-blockers at arrival
Proportion of β-blockers use within 24 hours of admission among eligible patients
Measured: 24 hours after admission
ECG at arrival
Proportion of ECG test within 10 minutes of admission among eligible patients
Measured: 24 hours after admission
Reperfusion therapy rate
Reperfusion therapy rate is defined as utilization rate of thrombolytic therapy or primary PCI treatment among patients indicated with the reperfusion therapy.
Measured: 24 hours after admission
Time delay from failure of fibrinolysis to angiography(The time from start of fibrinolysis to evaluation of its efficacy is 60-90min)
The proportion of failure of fibrinolysis to balloon within 90 minutes among all patients receiving PCI.
Measured: 10 days on average (during hospitalization)
Time delay from start of fibrinolysis to angiography(if fibrinolysis is successful)
The proportion of from fibrinolysis to balloon (if fibrinolysis is successful) within 2-24hours among all patients receiving PCI.
Measured: 10 days on average (during hospitalization)
Timeliness of thrombolytic therapy
The proportion of door to needle time (D2N) within 30 minutes among all patients receiving fibrinolytic therapy.
Measured: 24 hours after admission
Timeliness of primary PCI
The proportion of door to balloon (D2B) within 90 minutes among all patients receiving primary PCI.
Measured: 24 hours after admission
Door-in-Door-Out Time
Percentage of patients whose median time from the emergency department arrival at STEMI referral facility to emergency department discharge from STEMI referral facility is equal or less than 30 min. discharge from STEMI referral facility is 30 min.
Measured: 24 hours after admission
Time to Primary PCI Among Transferred Patients
Percentage of patients whose median time from first medical contact (at or before emergency department arrival to the STEMI referral facility [e.g., non-PCI-capable facility]) to primary PCI at the STEMI receiving facility (PCI-capable facility) is equal or less than 120 min
Measured: 24 hours after admission
Evaluation of LDL-C
Percentage of patients with documentation in the hospital record that LDL-C is evaluated during hospitalization
Measured: 10 days on average (during hospitalization)
Evaluation of left ventricular ejection fraction
Percentage of patients with documentation in the hospital record that left ventricular ejection fraction is evaluated during hospitalization
Measured: 10 days on average (during hospitalization)
Aspirin use during hospitalization
Proportion of Aspirin use during hospitalization among eligible patients.
Measured: 10 days on average (during hospitalization)
Clopidogrel (or ticagrelor) use during hospitalization
Proportion of Clopidogrel (or ticagrelor) use during hospitalization among eligible patients.
Measured: 10 days on average (during hospitalization)
β-blockers use during hospitalization
Proportion of β-blockers use during hospitalization among eligible patients.
Measured: 10 days on average (during hospitalization)
Angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker use during hospitalization
Proportion of Angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker use during hospitalization among eligible patients.
Measured: 10 days on average (during hospitalization)
Statins use during hospitalization
Proportion of statins use during hospitalization among eligible patients.
Measured: 10 days on average (during hospitalization)
Aspirin use at discharge
Proportion of aspirin use at discharge among eligible patients.
Measured: 10 days on average (during hospitalization)
Clopidogrel (or ticagrelor) use at discharge
Proportion of Clopidogrel (or ticagrelor) use at discharge among eligible patients.
Measured: 10 days on average (during hospitalization)
β-blockers use at discharge
Proportion of β-blockers use at discharge among eligible patients.
Measured: 10 days on average (during hospitalization)
angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker use at discharge
Proportion of angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker use at discharge among eligible patients.
Measured: 10 days on average (during hospitalization)
Statins use at discharge
Proportion of statins use at discharge among eligible patients.
Measured: 10 days on average (during hospitalization)
Aldosterone Antagonist at Discharge
Proportion of Aldosterone Antagonist use at discharge among eligible patients.
Measured: 10 days on average (during hospitalization)
Smoking cessation advice/ counseling at Discharge
Proportion of patients received smoking cessation advice/ counseling
Measured: 10 days on average (during hospitalization)
all-cause mortality during hospitalization
Proportion of patients who were all-cause death during hospitalization
Measured: 10 days on average (during hospitalization)
Cardiac mortality during hospitalization
Proportion of patients who were cardiac death during hospitalization
Measured: 10 days on average (during hospitalization)
30-day all-cause mortality
Proportion of patients who were all-cause death from admission to 30days
Measured: From admission to 30days
30-day cardiac mortality
Proportion of patients who were cardiac death from admission to 30days
Measured: From admission to 30days
30-day readmission rates
Proportion of patients readmission from hospital discharge to 30days
Measured: From hospital discharge to 30 days
Cost during hospitalization
Cost during hospitalization
Measured: 10 days on average (during hospitalization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study start15 Jul 2018
- Primary completion31 Dec 2035 (estimated)
- Study completion31 Dec 2035 (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 China National Center for Cardiovascular DiseasesThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Zhe Zheng, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04088682
- Sponsor's protocol ID
- NCCQI-CAD
- Status last verified
- Sep 2019
- First submitted
- 9 Sep 2019
- Last updated
- 9 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance and Quality Measures for Adults With Acute ST-Elevation Myocardial Infarction in China
- ClinicalTrials.gov ID
- NCT04088682
- Acronym / sponsor ID
- NCCQI-CAD
- Conditions
- ST Elevation Myocardial Infarction
- Keywords
- clinical performance, quality measures, ST-Elevation myocardial infarction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200,000 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 15 Jul 2018 (actual)
- Primary completion
- 31 Dec 2035 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 13 Sep 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.
This study aims to investigate and evaluate clinical performance and quality measures for adults with acute ST-elevation myocardial infarction (STEMI) in China. Further more, the investigates like to develop quality improvement strategies and relevant tools focusing on treatment and clinical outcome in patients with STEMI. This is a annually survey , through consecutively recruiting all eligible inpatients and collecting relevant medical information, the performance of all participating hospitals. Further, quality improvement strategies including summary of clinical performance and quality measures, clinical pathways and team building will be organized for the purpose of quality improvement. All hospitals will consecutively recruit qualified patients in the same method adopted in baseline period. Then the reperfusion rates and other performance measures will be compared annually.
Detailed description
Cardiovascular disease (CVD) is a major concern in public health globally, as well as in China, and remarkable variations of resources available and health system performance have been noted. Acute myocardial infarction is one of the leading causes of mortality and morbidity, both in rural and urban area.
This study aims to investigate and evaluate clinical performance and quality measures for adults with acute ST-elevation myocardial infarction (STEMI) in China. Further more, the investigates like to develop quality improvement strategies and relevant tools focusing on treatment and clinical outcome in patients with STEMI.
This is a annually survey , through consecutively recruiting all eligible inpatients and collecting relevant medical information, the performance of all participating hospitals. Demographic characteristics, clinical features, diagnostic tests, medications, procedures, and in-hospital outcomes of patients will be obtained and then, the treatment pattern and outcomes will be evaluated. Further, quality improvement strategies including summary of clinical performance and quality measures, clinical pathways and professional training will be organized for the purpose of quality improvement. All hospitals will consecutively recruit qualified patients in the same method adopted in baseline period. Then the reperfusion rates and other performance measures will be compared annually.
New knowledge will be generated about STEMI management in China, to improve STEMI patients prognosis in future.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All hospitals | – | Behavioral: Quality improvement strategies and toolsAll hospitals will take the treatment quality improvement strategies and tools into implementation. Intervention: Behavioral: Quality improvement strategies and tools |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with STEMI who arrive at the hospital within 48 hours from the symptoms onset
Key inclusion criteria (1 listed)
- Patients with STEMI who arrive at the hospital within 48 hours from the symptoms onset.
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 |
|---|---|---|
| Quality improvement strategies and toolsQuality improvement strategies and tools | Behavioural | All hospitals |
Primary outcome
Aspirin at arrival
Time frame: 24 hours after admission
Proportion of aspirin use within 24 hours of admission among eligible patients
Clopidogrel (or ticagrelor) at arrival
Time frame: 24 hours after admission
Proportion of Clopidogrel (or ticagrelor) use within 24 hours of admission among eligible patients
β-blockers at arrival
Time frame: 24 hours after admission
Proportion of β-blockers use within 24 hours of admission among eligible patients
ECG at arrival
Time frame: 24 hours after admission
Proportion of ECG test within 10 minutes of admission among eligible patients
Reperfusion therapy rate
Time frame: 24 hours after admission
Reperfusion therapy rate is defined as utilization rate of thrombolytic therapy or primary PCI treatment among patients indicated with the reperfusion therapy.
Time delay from failure of fibrinolysis to angiography(The time from start of fibrinolysis to evaluation of its efficacy is 60-90min)
Time frame: 10 days on average (during hospitalization)
The proportion of failure of fibrinolysis to balloon within 90 minutes among all patients receiving PCI.
Time delay from start of fibrinolysis to angiography(if fibrinolysis is successful)
Time frame: 10 days on average (during hospitalization)
The proportion of from fibrinolysis to balloon (if fibrinolysis is successful) within 2-24hours among all patients receiving PCI.
Timeliness of thrombolytic therapy
Time frame: 24 hours after admission
The proportion of door to needle time (D2N) within 30 minutes among all patients receiving fibrinolytic therapy.
Timeliness of primary PCI
Time frame: 24 hours after admission
The proportion of door to balloon (D2B) within 90 minutes among all patients receiving primary PCI.
Door-in-Door-Out Time
Time frame: 24 hours after admission
Percentage of patients whose median time from the emergency department arrival at STEMI referral facility to emergency department discharge from STEMI referral facility is equal or less than 30 min. discharge from STEMI referral facility is 30 min.
Time to Primary PCI Among Transferred Patients
Time frame: 24 hours after admission
Percentage of patients whose median time from first medical contact (at or before emergency department arrival to the STEMI referral facility [e.g., non-PCI-capable facility]) to primary PCI at the STEMI receiving facility (PCI-capable facility) is equal or less than 120 min
Evaluation of LDL-C
Time frame: 10 days on average (during hospitalization)
Percentage of patients with documentation in the hospital record that LDL-C is evaluated during hospitalization
Evaluation of left ventricular ejection fraction
Time frame: 10 days on average (during hospitalization)
Percentage of patients with documentation in the hospital record that left ventricular ejection fraction is evaluated during hospitalization
Aspirin use during hospitalization
Time frame: 10 days on average (during hospitalization)
Proportion of Aspirin use during hospitalization among eligible patients.
Clopidogrel (or ticagrelor) use during hospitalization
Time frame: 10 days on average (during hospitalization)
Proportion of Clopidogrel (or ticagrelor) use during hospitalization among eligible patients.
β-blockers use during hospitalization
Time frame: 10 days on average (during hospitalization)
Proportion of β-blockers use during hospitalization among eligible patients.
Angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker use during hospitalization
Time frame: 10 days on average (during hospitalization)
Proportion of Angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker use during hospitalization among eligible patients.
Statins use during hospitalization
Time frame: 10 days on average (during hospitalization)
Proportion of statins use during hospitalization among eligible patients.
Aspirin use at discharge
Time frame: 10 days on average (during hospitalization)
Proportion of aspirin use at discharge among eligible patients.
Clopidogrel (or ticagrelor) use at discharge
Time frame: 10 days on average (during hospitalization)
Proportion of Clopidogrel (or ticagrelor) use at discharge among eligible patients.
β-blockers use at discharge
Time frame: 10 days on average (during hospitalization)
Proportion of β-blockers use at discharge among eligible patients.
angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker use at discharge
Time frame: 10 days on average (during hospitalization)
Proportion of angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker use at discharge among eligible patients.
Statins use at discharge
Time frame: 10 days on average (during hospitalization)
Proportion of statins use at discharge among eligible patients.
Aldosterone Antagonist at Discharge
Time frame: 10 days on average (during hospitalization)
Proportion of Aldosterone Antagonist use at discharge among eligible patients.
Smoking cessation advice/ counseling at Discharge
Time frame: 10 days on average (during hospitalization)
Proportion of patients received smoking cessation advice/ counseling
all-cause mortality during hospitalization
Time frame: 10 days on average (during hospitalization)
Proportion of patients who were all-cause death during hospitalization
Cardiac mortality during hospitalization
Time frame: 10 days on average (during hospitalization)
Proportion of patients who were cardiac death during hospitalization
30-day all-cause mortality
Time frame: From admission to 30days
Proportion of patients who were all-cause death from admission to 30days
30-day cardiac mortality
Time frame: From admission to 30days
Proportion of patients who were cardiac death from admission to 30days
30-day readmission rates
Time frame: From hospital discharge to 30 days
Proportion of patients readmission from hospital discharge to 30days
Cost during hospitalization
Time frame: 10 days on average (during hospitalization)
Cost during hospitalization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
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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.
Zhe Zheng principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
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 China National Center for Cardiovascular Diseases 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: looking for participants now, as of the sponsor's last update on 9 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongjian Wang (13910008985 ext. 13910008985, wanghongjianfw@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aspirin at arrival (time frame: 24 hours after admission). The study lists 31 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 9 Oct 2019.