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NCT Number: NCT04088682

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.

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Key information

Conditions

ST Elevation Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hongjian Wang

Beijing, Beijing Municipality, 100037, China

Location status: Recruiting

Location contact

Hongjian Wang

CONTACT

[email protected]

13910008985 ext. 13910008985

Yin Dong

CONTACT

13552582795

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Quality improvement strategies and tools

Behavioral

Quality improvement strategies and tools

Primary outcomes

  1. Aspirin at arrival

    Time frame: 24 hours after admission

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

  2. 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

  3. β-blockers at arrival

    Time frame: 24 hours after admission

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

  4. ECG at arrival

    Time frame: 24 hours after admission

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

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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

  12. 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

  13. 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

  14. Aspirin use during hospitalization

    Time frame: 10 days on average (during hospitalization)

    Proportion of Aspirin use during hospitalization among eligible patients.

  15. 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.

  16. β-blockers use during hospitalization

    Time frame: 10 days on average (during hospitalization)

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

  17. 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.

  18. Statins use during hospitalization

    Time frame: 10 days on average (during hospitalization)

    Proportion of statins use during hospitalization among eligible patients.

  19. Aspirin use at discharge

    Time frame: 10 days on average (during hospitalization)

    Proportion of aspirin use at discharge among eligible patients.

  20. 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.

  21. β-blockers use at discharge

    Time frame: 10 days on average (during hospitalization)

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

  22. 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.

  23. Statins use at discharge

    Time frame: 10 days on average (during hospitalization)

    Proportion of statins use at discharge among eligible patients.

  24. Aldosterone Antagonist at Discharge

    Time frame: 10 days on average (during hospitalization)

    Proportion of Aldosterone Antagonist use at discharge among eligible patients.

  25. Smoking cessation advice/ counseling at Discharge

    Time frame: 10 days on average (during hospitalization)

    Proportion of patients received smoking cessation advice/ counseling

  26. all-cause mortality during hospitalization

    Time frame: 10 days on average (during hospitalization)

    Proportion of patients who were all-cause death during hospitalization

  27. Cardiac mortality during hospitalization

    Time frame: 10 days on average (during hospitalization)

    Proportion of patients who were cardiac death during hospitalization

  28. 30-day all-cause mortality

    Time frame: From admission to 30days

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

  29. 30-day cardiac mortality

    Time frame: From admission to 30days

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

  30. 30-day readmission rates

    Time frame: From hospital discharge to 30 days

    Proportion of patients readmission from hospital discharge to 30days

  31. Cost during hospitalization

    Time frame: 10 days on average (during hospitalization)

    Cost during hospitalization

Study contacts

Contact information is provided by the study sponsor or research team.

Hongjian Wang

CONTACT

[email protected]

13910008985 ext. 13910008985

Kefei Dou

CONTACT

[email protected]

13801032912

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Important dates

Study start
2018
Primary completion
2035
Study completion
2035
First posted
Sep 13, 2019
Registry last updated
Oct 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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