跳至主要内容
临床试验/NCT04088682
NCT04088682招募中不适用

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

China National Center for Cardiovascular Diseases1 个研究点 分布在 1 个国家目标入组 200,000 人开始时间: 2018年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200,000
试验地点
1
主要终点
Timeliness of thrombolytic therapy

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 未提供

结局指标

主要结局

Timeliness of thrombolytic therapy

时间窗: 24 hours after admission

The proportion of door to needle time (D2N) within 30 minutes among all patients receiving fibrinolytic therapy.

Door-in-Door-Out Time

时间窗: 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.

Statins use during hospitalization

时间窗: 10 days on average (during hospitalization)

Proportion of statins use during hospitalization among eligible patients.

Aspirin use at discharge

时间窗: 10 days on average (during hospitalization)

Proportion of aspirin use at discharge among eligible patients.

ECG at arrival

时间窗: 24 hours after admission

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

Timeliness of primary PCI

时间窗: 24 hours after admission

The proportion of door to balloon (D2B) within 90 minutes among all patients receiving primary PCI.

Evaluation of left ventricular ejection fraction

时间窗: 10 days on average (during hospitalization)

Percentage of patients with documentation in the hospital record that left ventricular ejection fraction is evaluated during hospitalization

Aspirin use during hospitalization

时间窗: 10 days on average (during hospitalization)

Proportion of Aspirin use during hospitalization among eligible patients.

Angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker use during hospitalization

时间窗: 10 days on average (during hospitalization)

Proportion of Angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker use during hospitalization among eligible patients.

Clopidogrel (or ticagrelor) use at discharge

时间窗: 10 days on average (during hospitalization)

Proportion of Clopidogrel (or ticagrelor) use at discharge among eligible patients.

Statins use at discharge

时间窗: 10 days on average (during hospitalization)

Proportion of statins use at discharge among eligible patients.

Aldosterone Antagonist at Discharge

时间窗: 10 days on average (during hospitalization)

Proportion of Aldosterone Antagonist use at discharge among eligible patients.

Cardiac mortality during hospitalization

时间窗: 10 days on average (during hospitalization)

Proportion of patients who were cardiac death during hospitalization

30-day readmission rates

时间窗: From hospital discharge to 30 days

Proportion of patients readmission from hospital discharge to 30days

Aspirin at arrival

时间窗: 24 hours after admission

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

Clopidogrel (or ticagrelor) at arrival

时间窗: 24 hours after admission

Proportion of Clopidogrel (or ticagrelor) use within 24 hours of admission among eligible patients

β-blockers at arrival

时间窗: 24 hours after admission

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

Reperfusion therapy rate

时间窗: 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.

Time delay from failure of fibrinolysis to angiography(The time from start of fibrinolysis to evaluation of its efficacy is 60-90min)

时间窗: 10 days on average (during hospitalization)

The proportion of failure of fibrinolysis to balloon within 90 minutes among all patients receiving PCI.

Time delay from start of fibrinolysis to angiography(if fibrinolysis is successful)

时间窗: 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.

β-blockers use at discharge

时间窗: 10 days on average (during hospitalization)

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

β-blockers use during hospitalization

时间窗: 10 days on average (during hospitalization)

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

Clopidogrel (or ticagrelor) use during hospitalization

时间窗: 10 days on average (during hospitalization)

Proportion of Clopidogrel (or ticagrelor) use during hospitalization among eligible patients.

30-day cardiac mortality

时间窗: From admission to 30days

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

Time to Primary PCI Among Transferred Patients

时间窗: 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

Evaluation of LDL-C

时间窗: 10 days on average (during hospitalization)

Percentage of patients with documentation in the hospital record that LDL-C is evaluated during hospitalization

angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker use at discharge

时间窗: 10 days on average (during hospitalization)

Proportion of angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker use at discharge among eligible patients.

Smoking cessation advice/ counseling at Discharge

时间窗: 10 days on average (during hospitalization)

Proportion of patients received smoking cessation advice/ counseling

all-cause mortality during hospitalization

时间窗: 10 days on average (during hospitalization)

Proportion of patients who were all-cause death during hospitalization

30-day all-cause mortality

时间窗: From admission to 30days

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

Cost during hospitalization

时间窗: 10 days on average (during hospitalization)

Cost during hospitalization

次要结局

未报告次要终点

研究者

发起方
China National Center for Cardiovascular Diseases
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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