Clinical trial NCT04088682: Clinical Performance and Quality Measures for Adults With Acute ST-Elevation Myocardial Infarction in China
Official title: Clinical Performance and Quality Measures for Adults With Acute ST-Elevation Myocardial Infarction in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ST Elevation Myocardial Infarction
Keywords: clinical performance
quality measures
ST-Elevation myocardial infarction
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2019-09-13
Enrollment: 200000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with STEMI who arrive at the hospital within 48 hours from the symptoms onset

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.

Eligibility criteria: Inclusion Criteria:

* Patients with STEMI who arrive at the hospital within 48 hours from the symptoms onset.

Exclusion Criteria:

* None

Primary outcomes:
measure: Aspirin at arrival
timeFrame: 24 hours after admission
measure: Clopidogrel (or ticagrelor) at arrival
timeFrame: 24 hours after admission
measure: β-blockers at arrival
timeFrame: 24 hours after admission
measure: ECG at arrival
timeFrame: 24 hours after admission
measure: Reperfusion therapy rate
timeFrame: 24 hours after admission
measure: Time delay from failure of fibrinolysis to angiography(The time from start of fibrinolysis to evaluation of its efficacy is 60-90min)
timeFrame: 10 days on average (during hospitalization)
measure: Time delay from start of fibrinolysis to angiography(if fibrinolysis is successful)
timeFrame: 10 days on average (during hospitalization)
measure: Timeliness of thrombolytic therapy
timeFrame: 24 hours after admission
measure: Timeliness of primary PCI
timeFrame: 24 hours after admission
measure: Door-in-Door-Out Time
timeFrame: 24 hours after admission
measure: Time to Primary PCI Among Transferred Patients
timeFrame: 24 hours after admission
measure: Evaluation of LDL-C
timeFrame: 10 days on average (during hospitalization)
measure: Evaluation of left ventricular ejection fraction
timeFrame: 10 days on average (during hospitalization)
measure: Aspirin use during hospitalization
timeFrame: 10 days on average (during hospitalization)
measure: Clopidogrel (or ticagrelor) use during hospitalization
timeFrame: 10 days on average (during hospitalization)
measure: β-blockers use during hospitalization
timeFrame: 10 days on average (during hospitalization)
measure: Angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker use during hospitalization
timeFrame: 10 days on average (during hospitalization)
measure: Statins use during hospitalization
timeFrame: 10 days on average (during hospitalization)
measure: Aspirin use at discharge
timeFrame: 10 days on average (during hospitalization)
measure: Clopidogrel (or ticagrelor) use at discharge
timeFrame: 10 days on average (during hospitalization)
measure: β-blockers use at discharge
timeFrame: 10 days on average (during hospitalization)
measure: angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker use at discharge
timeFrame: 10 days on average (during hospitalization)
measure: Statins use at discharge
timeFrame: 10 days on average (during hospitalization)
measure: Aldosterone Antagonist at Discharge
timeFrame: 10 days on average (during hospitalization)
measure: Smoking cessation advice/ counseling at Discharge
timeFrame: 10 days on average (during hospitalization)
measure: all-cause mortality during hospitalization
timeFrame: 10 days on average (during hospitalization)
measure: Cardiac mortality during hospitalization
timeFrame: 10 days on average (during hospitalization)
measure: 30-day all-cause mortality
timeFrame: From admission to 30days
measure: 30-day cardiac mortality
timeFrame: From admission to 30days
measure: 30-day readmission rates
timeFrame: From hospital discharge to 30 days
measure: Cost during hospitalization
timeFrame: 10 days on average (during hospitalization)
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Hongjian Wang
state: Beijing
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Zhe Zheng
role: PRINCIPAL_INVESTIGATOR
References: