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Clinical Performance and Quality Measures for Adults With Acute ST-Elevation Myocardial Infarction in China

Recruiting
Conditions
ST Elevation Myocardial Infarction
Interventions
Behavioral: Quality improvement strategies and tools
Registration Number
NCT04088682
Lead Sponsor
China National Center for Cardiovascular Diseases
Brief 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 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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
200000
Inclusion Criteria
  • Patients with STEMI who arrive at the hospital within 48 hours from the symptoms onset.
Exclusion Criteria
  • None

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
All hospitalsQuality improvement strategies and toolsAll hospitals will take the treatment quality improvement strategies and tools into implementation. Intervention: Behavioral: Quality improvement strategies and tools
Primary Outcome Measures
NameTimeMethod
Timeliness of primary PCI24 hours after admission

The proportion of door to balloon (D2B) within 90 minutes among all patients receiving primary PCI.

Timeliness of thrombolytic therapy24 hours after admission

The proportion of door to needle time (D2N) within 30 minutes among all patients receiving fibrinolytic therapy.

Door-in-Door-Out Time24 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.

Statins use during hospitalization10 days on average (during hospitalization)

Proportion of statins use during hospitalization among eligible patients.

Aspirin use at discharge10 days on average (during hospitalization)

Proportion of aspirin use at discharge among eligible patients.

Evaluation of left ventricular ejection fraction10 days on average (during hospitalization)

Percentage of patients with documentation in the hospital record that left ventricular ejection fraction is evaluated during hospitalization

ECG at arrival24 hours after admission

Proportion of ECG test within 10 minutes of admission among eligible patients

Aspirin use during hospitalization10 days on average (during hospitalization)

Proportion of Aspirin use during hospitalization among eligible patients.

Angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker use during hospitalization10 days on average (during hospitalization)

Proportion of Angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker use during hospitalization among eligible patients.

Clopidogrel (or ticagrelor) use at discharge10 days on average (during hospitalization)

Proportion of Clopidogrel (or ticagrelor) use at discharge among eligible patients.

Statins use at discharge10 days on average (during hospitalization)

Proportion of statins use at discharge among eligible patients.

Aldosterone Antagonist at Discharge10 days on average (during hospitalization)

Proportion of Aldosterone Antagonist use at discharge among eligible patients.

Cardiac mortality during hospitalization10 days on average (during hospitalization)

Proportion of patients who were cardiac death during hospitalization

30-day readmission ratesFrom hospital discharge to 30 days

Proportion of patients readmission from hospital discharge to 30days

Aspirin at arrival24 hours after admission

Proportion of aspirin use within 24 hours of admission among eligible patients

Clopidogrel (or ticagrelor) at arrival24 hours after admission

Proportion of Clopidogrel (or ticagrelor) use within 24 hours of admission among eligible patients

β-blockers at arrival24 hours after admission

Proportion of β-blockers use within 24 hours of admission among eligible patients

Reperfusion therapy rate24 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.

all-cause mortality during hospitalization10 days on average (during hospitalization)

Proportion of patients who were all-cause death during hospitalization

Time delay from failure of fibrinolysis to angiography(The time from start of fibrinolysis to evaluation of its efficacy is 60-90min)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)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.

β-blockers use at discharge10 days on average (during hospitalization)

Proportion of β-blockers use at discharge among eligible patients.

β-blockers use during hospitalization10 days on average (during hospitalization)

Proportion of β-blockers use during hospitalization among eligible patients.

Clopidogrel (or ticagrelor) use during hospitalization10 days on average (during hospitalization)

Proportion of Clopidogrel (or ticagrelor) use during hospitalization among eligible patients.

30-day cardiac mortalityFrom admission to 30days

Proportion of patients who were cardiac death from admission to 30days

Time to Primary PCI Among Transferred Patients24 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-C10 days on average (during hospitalization)

Percentage of patients with documentation in the hospital record that LDL-C is evaluated during hospitalization

angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker use at discharge10 days on average (during hospitalization)

Proportion of angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker use at discharge among eligible patients.

Smoking cessation advice/ counseling at Discharge10 days on average (during hospitalization)

Proportion of patients received smoking cessation advice/ counseling

30-day all-cause mortalityFrom admission to 30days

Proportion of patients who were all-cause death from admission to 30days

Cost during hospitalization10 days on average (during hospitalization)

Cost during hospitalization

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Hongjian Wang

🇨🇳

Beijing, Beijing, China

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