Echocardiography by Non-cardiologist in Early Management of Patients With Chest Pain (ENDEMIC)
研究概览
详细说明
Emergent echocardiography is reproducible method providing clinically significant information during primary survey of acute cardiovascular diseases. Possible benefit is the risk stratification of acute non-stemi coronary syndromes and differentiation from other serious conditions, such as pulmonary embolism or aortic dissection.
Step one - Education in Cardiac ultrasound. All physicians involved in ENDEMIC study have to undergo education program of heart ultrasonography. This curriculum fulfills BSE level one requirements. Candidates of this program have to make a defined number of ECHOcardiography studies under supervisor control. Every curriculum is finished by exam.
Step two - FOCUS in clinical practise Patients with chest pain are randomized into two groups by the even-odd rule.
Inclusion Criteria:
Chest pain ( Cardiovascular ethiology possible depends on anamnesis, physical examination and ECG ) Higher age than 18
Exclusion Criteria:
STEMI Pacemaker / ICD Pregnancy Performance status 4 ( Zubrod scale ) Informed Consent unsigned Prisoners
Step Three - Evaluation
Aims.:
Compare time to make a decision in these groups Compare time of stay at emergency department in these groups Compare time to invasive coronary angiography and revascularization (if available) Compare time to hospital dimission Occurrence of MACE in following 30 days
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Petr Grenar, MD
- 电话号码:+420724027318
- 邮箱:petr.grenar@fnhk.cz
研究联系人备份
- 姓名:Martin Jakl, assoc.prof.
- 电话号码:+420607514962
- 邮箱:martin.jakl@fnhk.cz
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Chest pain ( Cardiovascular ethiology possible depends on anamnesis, physical examination and ECG )
- Higher age than 18
Exclusion Criteria:
- STEMI
- Pacemaker / ICD
- Pregnancy
- Performance status 4 ( Zubrod scale )
- Informed Consent unsigned
- Prisoners
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:FOCUS group
Group of patients with chest pain undergoing FOCUS ( Focused Cardiac Ultrasound ). Patients with odd registration number. |
Emergent echocardiography is reproducible method providing clinically significant information during primary survey of acute cardiovascular diseases.
Possible benefit is the risk stratification of acute non-stemi coronary syndromes and differentiation from other serious conditions, such as pulmonary embolism or aortic dissection.
The aim of interest is to consider riscs and benefits of the ultrasound of heart done by non-cardiologist after standardized course.
|
|
有源比较器:Non-FOCUS group
Patients with even registration number.
|
Emergent echocardiography is reproducible method providing clinically significant information during primary survey of acute cardiovascular diseases.
Possible benefit is the risk stratification of acute non-stemi coronary syndromes and differentiation from other serious conditions, such as pulmonary embolism or aortic dissection.
The aim of interest is to consider riscs and benefits of the ultrasound of heart done by non-cardiologist after standardized course.
|
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 |
|---|---|---|
|
Time of patient stay at Emergency Department
大体时间:24 hours
|
Time from initial contact with patient to patient discharge or hospital admission (minutes)
|
24 hours
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time of stay at hospital
大体时间:28 days
|
Time from hospital admission to hospital discharge (hours)
|
28 days
|
|
Major adverse cardiovascular events
大体时间:30 days
|
Major adverse cardiovascular events are defined as composite endpoint of cardiovascular death, nonfatal myocardial infarction or unscheduled hospitalization due to cardiovascular disease (percent of patients in study groups).
|
30 days
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to Coronary Angiography
大体时间:365 days
|
Time from initial contact to coronary angiography (days)
|
365 days
|
|
Accuracy of thoracic ultrasound exam provided by non-cardiologist
大体时间:30 days
|
All echocardiography records will be revised by skilled echocardiographist to assess the accuracy of performed examinations.
All missed or erroneous finding resulting in alteration of patient management (especially wall motion abnormity, valvular disease and pericardial effusion) will be calculated.
(quantity of erroneous or missed findings per record)
|
30 days
|
合作者和调查者
调查人员
- 研究主任:Martin Jakl, assoc.prof.、University of Defense, Faculty of Military Health Sciences, Czech Republic
- 首席研究员:Petr Grenar, MD、University of Defense, Faculty of Military Health Sciences, Czech Republic
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
To be shared:
- baseline characteristics of study population
- data related to primary and secondary endpoints
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 企业社会责任
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