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

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.

Study Overview

• Status: Recruiting
• Conditions: ST Elevation Myocardial Infarction
• Intervention / Treatment: Behavioral: Quality improvement strategies and tools

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 Type: Observational
• Enrollment (Anticipated): 200000

Contacts and Locations

• Study Contact: Name: Hongjian Wang; Phone Number: 13910008985 13910008985; Email: wanghongjianfw@hotmail.com
• Study Contact Backup: Name: Kefei Dou; Phone Number: 13801032912; Email: drdoukefei@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • Recruiting
      • Hongjian Wang
      • Contact: Hongjian Wang; Phone Number: 13910008985 13910008985; Email: wanghongjianfw@hotmail.com
      • Contact: Yin Dong; Phone Number: 13552582795

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All hospitals; All hospitals will take the treatment quality improvement strategies and tools into implementation. Intervention: Behavioral: Quality improvement strategies and tools	Behavioral: Quality improvement strategies and tools; Quality improvement strategies and tools

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aspirin at arrival	Proportion of aspirin use within 24 hours of admission among eligible patients	24 hours after admission
Clopidogrel (or ticagrelor) at arrival	Proportion of Clopidogrel (or ticagrelor) use within 24 hours of admission among eligible patients	24 hours after admission
β-blockers at arrival	Proportion of β-blockers use within 24 hours of admission among eligible patients	24 hours after admission
ECG at arrival	Proportion of ECG test within 10 minutes of admission among eligible patients	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.	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.	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.	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.	24 hours after admission
Timeliness of primary PCI	The proportion of door to balloon (D2B) within 90 minutes among all patients receiving primary PCI.	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.	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	24 hours after admission
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)
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)
Aspirin use during hospitalization	Proportion of Aspirin use during hospitalization among eligible patients.	10 days on average (during hospitalization)
Clopidogrel (or ticagrelor) use during hospitalization	Proportion of Clopidogrel (or ticagrelor) use during hospitalization among eligible patients.	10 days on average (during hospitalization)
β-blockers use during hospitalization	Proportion of β-blockers use during hospitalization among eligible patients.	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.	10 days on average (during hospitalization)
Statins use during hospitalization	Proportion of statins use during hospitalization among eligible patients.	10 days on average (during hospitalization)
Aspirin use at discharge	Proportion of aspirin use at discharge among eligible patients.	10 days on average (during hospitalization)
Clopidogrel (or ticagrelor) use at discharge	Proportion of Clopidogrel (or ticagrelor) use at discharge among eligible patients.	10 days on average (during hospitalization)
β-blockers use at discharge	Proportion of β-blockers use at discharge among eligible patients.	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.	10 days on average (during hospitalization)
Statins use at discharge	Proportion of statins use at discharge among eligible patients.	10 days on average (during hospitalization)
Aldosterone Antagonist at Discharge	Proportion of Aldosterone Antagonist use at discharge among eligible patients.	10 days on average (during hospitalization)
Smoking cessation advice/ counseling at Discharge	Proportion of patients received smoking cessation advice/ counseling	10 days on average (during hospitalization)
all-cause mortality during hospitalization	Proportion of patients who were all-cause death during hospitalization	10 days on average (during hospitalization)
Cardiac mortality during hospitalization	Proportion of patients who were cardiac death during hospitalization	10 days on average (during hospitalization)
30-day all-cause mortality	Proportion of patients who were all-cause death from admission to 30days	From admission to 30days
30-day cardiac mortality	Proportion of patients who were cardiac death from admission to 30days	From admission to 30days
30-day readmission rates	Proportion of patients readmission from hospital discharge to 30days	From hospital discharge to 30 days
Cost during hospitalization	Cost during hospitalization	10 days on average (during hospitalization)

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Investigators: Principal Investigator: Zhe Zheng, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2018
• Primary Completion (Anticipated): December 31, 2035
• Study Completion (Anticipated): December 31, 2035

Study Registration Dates

• First Submitted: September 9, 2019
• First Submitted That Met QC Criteria: September 12, 2019
• First Posted (Actual): September 13, 2019

Study Record Updates

• Last Update Posted (Actual): October 9, 2019
• Last Update Submitted That Met QC Criteria: October 8, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: clinical performance; quality measures; ST-Elevation myocardial infarction
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction
• Other Study ID Numbers: NCCQI-CAD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No