- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04088682
Clinical Performance and Quality Measures for Adults With Acute ST-Elevation Myocardial Infarction in China
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: Hongjian Wang
- 전화번호: 13910008985 13910008985
- 이메일: wanghongjianfw@hotmail.com
연구 연락처 백업
- 이름: Kefei Dou
- 전화번호: 13801032912
- 이메일: drdoukefei@126.com
연구 장소
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Beijing
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Beijing, Beijing, 중국, 100037
- 모병
- Hongjian Wang
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연락하다:
- Hongjian Wang
- 전화번호: 13910008985 13910008985
- 이메일: wanghongjianfw@hotmail.com
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연락하다:
- Yin Dong
- 전화번호: 13552582795
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Patients with STEMI who arrive at the hospital within 48 hours from the symptoms onset.
Exclusion Criteria:
- None
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 케이스 전용
- 시간 관점: 회고전
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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All hospitals
All hospitals will take the treatment quality improvement strategies and tools into implementation. Intervention: Behavioral: Quality improvement strategies and tools |
Quality improvement strategies and tools
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Aspirin at arrival
기간: 24 hours after admission
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Proportion of aspirin use within 24 hours of admission among eligible patients
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24 hours after admission
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Clopidogrel (or ticagrelor) at arrival
기간: 24 hours after admission
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Proportion of Clopidogrel (or ticagrelor) use within 24 hours of admission among eligible patients
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24 hours after admission
|
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β-blockers at arrival
기간: 24 hours after admission
|
Proportion of β-blockers use within 24 hours of admission among eligible patients
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24 hours after admission
|
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ECG at arrival
기간: 24 hours after admission
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Proportion of ECG test within 10 minutes of admission among eligible patients
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24 hours after admission
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재관류 치료율
기간: 입장 후 24시간
|
재관류 치료율은 재관류 치료가 필요한 환자 중 혈전용해제 또는 일차 PCI 치료를 이용하는 비율로 정의한다.
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입장 후 24시간
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Time delay from failure of fibrinolysis to angiography(The time from start of fibrinolysis to evaluation of its efficacy is 60-90min)
기간: 10 days on average (during hospitalization)
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The proportion of failure of fibrinolysis to balloon within 90 minutes among all patients receiving PCI.
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10 days on average (during hospitalization)
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Time delay from start of fibrinolysis to angiography(if fibrinolysis is successful)
기간: 10 days on average (during hospitalization)
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The proportion of from fibrinolysis to balloon (if fibrinolysis is successful) within 2-24hours among all patients receiving PCI.
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10 days on average (during hospitalization)
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혈전 용해 요법의 적시성
기간: 입장 후 24시간
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섬유소 용해 요법을 받는 모든 환자 중 30분 이내의 D2N(Door to Needle Time) 비율.
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입장 후 24시간
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Timeliness of primary PCI
기간: 24 hours after admission
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The proportion of door to balloon (D2B) within 90 minutes among all patients receiving primary PCI.
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24 hours after admission
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Door-in-Door-Out Time
기간: 24 hours after admission
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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.
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24 hours after admission
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Time to Primary PCI Among Transferred Patients
기간: 24 hours after admission
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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
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24 hours after admission
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Evaluation of LDL-C
기간: 10 days on average (during hospitalization)
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Percentage of patients with documentation in the hospital record that LDL-C is evaluated during hospitalization
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10 days on average (during hospitalization)
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Evaluation of left ventricular ejection fraction
기간: 10 days on average (during hospitalization)
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Percentage of patients with documentation in the hospital record that left ventricular ejection fraction is evaluated during hospitalization
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10 days on average (during hospitalization)
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Aspirin use during hospitalization
기간: 10 days on average (during hospitalization)
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Proportion of Aspirin use during hospitalization among eligible patients.
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10 days on average (during hospitalization)
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Clopidogrel (or ticagrelor) use during hospitalization
기간: 10 days on average (during hospitalization)
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Proportion of Clopidogrel (or ticagrelor) use during hospitalization among eligible patients.
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10 days on average (during hospitalization)
|
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입원 중 β-차단제 사용
기간: 평균 10일(입원 중)
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적격 환자 중 입원 중 β-차단제 사용 비율.
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평균 10일(입원 중)
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Angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker use during hospitalization
기간: 10 days on average (during hospitalization)
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Proportion of Angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker use during hospitalization among eligible patients.
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10 days on average (during hospitalization)
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입원 중 스타틴 사용
기간: 평균 10일(입원 중)
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적격 환자 중 입원 중 스타틴 사용 비율.
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평균 10일(입원 중)
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퇴원 시 아스피린 사용
기간: 평균 10일(입원 중)
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적격 환자 중 퇴원 시 아스피린 사용 비율.
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평균 10일(입원 중)
|
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퇴원 시 클로피도그렐(또는 티카그렐러) 사용
기간: 평균 10일(입원 중)
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적격 환자 중 퇴원 시 클로피도그렐(또는 티카그렐로) 사용 비율.
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평균 10일(입원 중)
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퇴원 시 사용하는 β-차단제
기간: 평균 10일(입원 중)
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적격 환자 중 퇴원 시 사용하는 β-차단제의 비율.
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평균 10일(입원 중)
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angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker use at discharge
기간: 10 days on average (during hospitalization)
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Proportion of angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker use at discharge among eligible patients.
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10 days on average (during hospitalization)
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퇴원 시 스타틴 사용
기간: 평균 10일(입원 중)
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적격 환자 중 퇴원 시 스타틴 사용 비율.
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평균 10일(입원 중)
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Aldosterone Antagonist at Discharge
기간: 10 days on average (during hospitalization)
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Proportion of Aldosterone Antagonist use at discharge among eligible patients.
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10 days on average (during hospitalization)
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Smoking cessation advice/ counseling at Discharge
기간: 10 days on average (during hospitalization)
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Proportion of patients received smoking cessation advice/ counseling
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10 days on average (during hospitalization)
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all-cause mortality during hospitalization
기간: 10 days on average (during hospitalization)
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Proportion of patients who were all-cause death during hospitalization
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10 days on average (during hospitalization)
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Cardiac mortality during hospitalization
기간: 10 days on average (during hospitalization)
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Proportion of patients who were cardiac death during hospitalization
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10 days on average (during hospitalization)
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30-day all-cause mortality
기간: From admission to 30days
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Proportion of patients who were all-cause death from admission to 30days
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From admission to 30days
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30-day cardiac mortality
기간: From admission to 30days
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Proportion of patients who were cardiac death from admission to 30days
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From admission to 30days
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30-day readmission rates
기간: From hospital discharge to 30 days
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Proportion of patients readmission from hospital discharge to 30days
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From hospital discharge to 30 days
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Cost during hospitalization
기간: 10 days on average (during hospitalization)
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Cost during hospitalization
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10 days on average (during hospitalization)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Zhe Zheng, Fuwai Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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