Clinical Performance and Quality Measures for Adults With Acute ST-Elevation Myocardial Infarction in China
2019年10月8日 更新者：China National Center for Cardiovascular Diseases
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.
研究概览
详细说明
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.
研究类型
观察性的
注册 (预期的)
200000
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Hongjian Wang
- 电话号码：13910008985 13910008985
- 邮箱：wanghongjianfw@hotmail.com
研究联系人备份
- 姓名：Kefei Dou
- 电话号码：13801032912
- 邮箱：drdoukefei@126.com
学习地点
-
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Beijing
-
Beijing、Beijing、中国、100037
- 招聘中
- Hongjian Wang
-
接触：
- Hongjian Wang
- 电话号码：13910008985 13910008985
- 邮箱：wanghongjianfw@hotmail.com
-
接触：
- Yin Dong
- 电话号码：13552582795
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
Patients with STEMI who arrive at the hospital within 48 hours from the symptoms onset
描述
Inclusion Criteria:
- Patients with STEMI who arrive at the hospital within 48 hours from the symptoms onset.
Exclusion Criteria:
- None
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：仅案例
- 时间观点：追溯
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
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
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Aspirin at arrival
大体时间：24 hours after admission
|
Proportion of aspirin use within 24 hours of admission among eligible patients
|
24 hours after admission
|
|
Clopidogrel (or ticagrelor) at arrival
大体时间：24 hours after admission
|
Proportion of Clopidogrel (or ticagrelor) use within 24 hours of admission among eligible patients
|
24 hours after admission
|
|
β-blockers at arrival
大体时间：24 hours after admission
|
Proportion of β-blockers use within 24 hours of admission among eligible patients
|
24 hours after admission
|
|
ECG at arrival
大体时间：24 hours after admission
|
Proportion of ECG test within 10 minutes of admission among eligible patients
|
24 hours after admission
|
|
再灌注治疗率
大体时间：入院后24小时
|
再灌注治疗率定义为接受再灌注治疗的患者溶栓治疗或直接 PCI 治疗的使用率。
|
入院后24小时
|
|
Time delay from failure of fibrinolysis to angiography(The time from start of fibrinolysis to evaluation of its efficacy is 60-90min)
大体时间：10 days on average (during hospitalization)
|
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)
大体时间：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.
|
10 days on average (during hospitalization)
|
|
溶栓治疗的及时性
大体时间：入院后24小时
|
在所有接受纤溶治疗的患者中，30 分钟内进门到针刺时间 (D2N) 的比例。
|
入院后24小时
|
|
Timeliness of primary PCI
大体时间：24 hours after admission
|
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
大体时间：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.
|
24 hours after admission
|
|
Time to Primary PCI Among Transferred Patients
大体时间：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
|
24 hours after admission
|
|
Evaluation of LDL-C
大体时间：10 days on average (during hospitalization)
|
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
大体时间：10 days on average (during hospitalization)
|
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
大体时间：10 days on average (during hospitalization)
|
Proportion of Aspirin use during hospitalization among eligible patients.
|
10 days on average (during hospitalization)
|
|
Clopidogrel (or ticagrelor) use during hospitalization
大体时间：10 days on average (during hospitalization)
|
Proportion of Clopidogrel (or ticagrelor) use during hospitalization among eligible patients.
|
10 days on average (during hospitalization)
|
|
住院期间使用β受体阻滞剂
大体时间：平均10天（住院期间）
|
符合条件的患者在住院期间使用 β 受体阻滞剂的比例。
|
平均10天（住院期间）
|
|
Angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker use during hospitalization
大体时间：10 days on average (during hospitalization)
|
Proportion of Angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker use during hospitalization among eligible patients.
|
10 days on average (during hospitalization)
|
|
住院期间他汀类药物的使用
大体时间：平均10天（住院期间）
|
符合条件的患者在住院期间使用他汀类药物的比例。
|
平均10天（住院期间）
|
|
出院时服用阿司匹林
大体时间：平均10天（住院期间）
|
符合条件的患者出院时使用阿司匹林的比例。
|
平均10天（住院期间）
|
|
出院时使用氯吡格雷（或替格瑞洛）
大体时间：平均10天（住院期间）
|
合格患者出院时使用氯吡格雷（或替格瑞洛）的比例。
|
平均10天（住院期间）
|
|
出院时使用 β 受体阻滞剂
大体时间：平均10天（住院期间）
|
符合条件的患者出院时使用 β 受体阻滞剂的比例。
|
平均10天（住院期间）
|
|
angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker use at discharge
大体时间：10 days on average (during hospitalization)
|
Proportion of angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker use at discharge among eligible patients.
|
10 days on average (during hospitalization)
|
|
出院时使用他汀类药物
大体时间：平均10天（住院期间）
|
符合条件的患者出院时使用他汀类药物的比例。
|
平均10天（住院期间）
|
|
Aldosterone Antagonist at Discharge
大体时间：10 days on average (during hospitalization)
|
Proportion of Aldosterone Antagonist use at discharge among eligible patients.
|
10 days on average (during hospitalization)
|
|
Smoking cessation advice/ counseling at Discharge
大体时间：10 days on average (during hospitalization)
|
Proportion of patients received smoking cessation advice/ counseling
|
10 days on average (during hospitalization)
|
|
all-cause mortality during hospitalization
大体时间：10 days on average (during hospitalization)
|
Proportion of patients who were all-cause death during hospitalization
|
10 days on average (during hospitalization)
|
|
Cardiac mortality during hospitalization
大体时间：10 days on average (during hospitalization)
|
Proportion of patients who were cardiac death during hospitalization
|
10 days on average (during hospitalization)
|
|
30-day all-cause mortality
大体时间：From admission to 30days
|
Proportion of patients who were all-cause death from admission to 30days
|
From admission to 30days
|
|
30-day cardiac mortality
大体时间：From admission to 30days
|
Proportion of patients who were cardiac death from admission to 30days
|
From admission to 30days
|
|
30-day readmission rates
大体时间：From hospital discharge to 30 days
|
Proportion of patients readmission from hospital discharge to 30days
|
From hospital discharge to 30 days
|
|
Cost during hospitalization
大体时间：10 days on average (during hospitalization)
|
Cost during hospitalization
|
10 days on average (during hospitalization)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Zhe Zheng、Fuwai Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年7月15日
初级完成 (预期的)
2035年12月31日
研究完成 (预期的)
2035年12月31日
研究注册日期
首次提交
2019年9月9日
首先提交符合 QC 标准的
2019年9月12日
首次发布 (实际的)
2019年9月13日
研究记录更新
最后更新发布 (实际的)
2019年10月9日
上次提交的符合 QC 标准的更新
2019年10月8日
最后验证
2019年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.