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

ST Elevation Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04088682
• Other study ID #: NCCQI-CAD
• Status: Recruiting
• Start date: July 15, 2018
• Est. completion date: December 31, 2035

Study information

• Verified date: September 2019
• Source: China National Center for Cardiovascular Diseases
• Contact: Hongjian Wang
• Phone: 13910008985
• Email: wanghongjianfw[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 200000
• Est. completion date: December 31, 2035
• Est. primary completion date: December 31, 2035
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

Behavioral:
• Quality improvement strategies and tools
Quality improvement strategies and tools

Locations

Country	Name	City	State
China	Hongjian Wang	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aspirin at arrival	Proportion of aspirin use within 24 hours of admission among eligible patients	24 hours after admission
Primary	Clopidogrel (or ticagrelor) at arrival	Proportion of Clopidogrel (or ticagrelor) use within 24 hours of admission among eligible patients	24 hours after admission
Primary	ß-blockers at arrival	Proportion of ß-blockers use within 24 hours of admission among eligible patients	24 hours after admission
Primary	ECG at arrival	Proportion of ECG test within 10 minutes of admission among eligible patients	24 hours after admission
Primary	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.	24 hours after admission
Primary	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.	10 days on average (during hospitalization)
Primary	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.	10 days on average (during hospitalization)
Primary	Timeliness of thrombolytic therapy	The proportion of door to needle time (D2N) within 30 minutes among all patients receiving fibrinolytic therapy.	24 hours after admission
Primary	Timeliness of primary PCI	The proportion of door to balloon (D2B) within 90 minutes among all patients receiving primary PCI.	24 hours after admission
Primary	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.	24 hours after admission
Primary	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	24 hours after admission
Primary	Evaluation of LDL-C	Percentage of patients with documentation in the hospital record that LDL-C is evaluated during hospitalization	10 days on average (during hospitalization)
Primary	Evaluation of left ventricular ejection fraction	Percentage of patients with documentation in the hospital record that left ventricular ejection fraction is evaluated during hospitalization	10 days on average (during hospitalization)
Primary	Aspirin use during hospitalization	Proportion of Aspirin use during hospitalization among eligible patients.	10 days on average (during hospitalization)
Primary	Clopidogrel (or ticagrelor) use during hospitalization	Proportion of Clopidogrel (or ticagrelor) use during hospitalization among eligible patients.	10 days on average (during hospitalization)
Primary	ß-blockers use during hospitalization	Proportion of ß-blockers use during hospitalization among eligible patients.	10 days on average (during hospitalization)
Primary	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.	10 days on average (during hospitalization)
Primary	Statins use during hospitalization	Proportion of statins use during hospitalization among eligible patients.	10 days on average (during hospitalization)
Primary	Aspirin use at discharge	Proportion of aspirin use at discharge among eligible patients.	10 days on average (during hospitalization)
Primary	Clopidogrel (or ticagrelor) use at discharge	Proportion of Clopidogrel (or ticagrelor) use at discharge among eligible patients.	10 days on average (during hospitalization)
Primary	ß-blockers use at discharge	Proportion of ß-blockers use at discharge among eligible patients.	10 days on average (during hospitalization)
Primary	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.	10 days on average (during hospitalization)
Primary	Statins use at discharge	Proportion of statins use at discharge among eligible patients.	10 days on average (during hospitalization)
Primary	Aldosterone Antagonist at Discharge	Proportion of Aldosterone Antagonist use at discharge among eligible patients.	10 days on average (during hospitalization)
Primary	Smoking cessation advice/ counseling at Discharge	Proportion of patients received smoking cessation advice/ counseling	10 days on average (during hospitalization)
Primary	all-cause mortality during hospitalization	Proportion of patients who were all-cause death during hospitalization	10 days on average (during hospitalization)
Primary	Cardiac mortality during hospitalization	Proportion of patients who were cardiac death during hospitalization	10 days on average (during hospitalization)
Primary	30-day all-cause mortality	Proportion of patients who were all-cause death from admission to 30days	From admission to 30days
Primary	30-day cardiac mortality	Proportion of patients who were cardiac death from admission to 30days	From admission to 30days
Primary	30-day readmission rates	Proportion of patients readmission from hospital discharge to 30days	From hospital discharge to 30 days
Primary	Cost during hospitalization	Cost during hospitalization	10 days on average (during hospitalization)