Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04088682
Recruitment Status : Recruiting
First Posted : September 13, 2019
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
ST Elevation Myocardial Infarction 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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 200000 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Clinical Performance and Quality Measures for Adults With Acute ST-Elevation Myocardial Infarction in China
Actual Study Start Date : July 15, 2018
Estimated Primary Completion Date : December 31, 2035
Estimated Study Completion Date : December 31, 2035

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

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




Primary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with STEMI who arrive at the hospital within 48 hours from the symptoms onset
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04088682


Contacts
Layout table for location contacts
Contact: Hongjian Wang 13910008985 ext 13910008985 wanghongjianfw@hotmail.com
Contact: Kefei Dou 13801032912 drdoukefei@126.com

Locations
Layout table for location information
China, Beijing
Hongjian Wang Recruiting
Beijing, Beijing, China, 100037
Contact: Hongjian Wang    13910008985 ext 13910008985    wanghongjianfw@hotmail.com   
Contact: Yin Dong    13552582795      
Sponsors and Collaborators
China National Center for Cardiovascular Diseases
Investigators
Layout table for investigator information
Principal Investigator: Zhe Zheng Fuwai Hospital

Layout table for additonal information
Responsible Party: China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier: NCT04088682     History of Changes
Other Study ID Numbers: NCCQI-CAD
First Posted: September 13, 2019    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: September 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by China National Center for Cardiovascular Diseases:
clinical performance
quality measures
ST-Elevation myocardial infarction
Additional relevant MeSH terms:
Layout table for MeSH terms
Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases