An Assessment of the HyperQ Signal for Detecting Ischemia During Dobutamine Stress Echocardiography (DSE)
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- HyperQ Signal recorded during the DES Test
研究概览
简要总结
The purpose of the study is to verify the ability of the HyperQ signal to detect Dobutamine induced Ischemia. The gold standard for ischemia will be the results of Angiography if performed, or Echocardiographic imaging, which was performed during the test.
详细描述
Subjects referred for Dobutamine Stress Echocardiography who will sign an Informed consent form will go through the test. High resolution ECG from 12 leads will be recorded using BSP's HyperQ system before, during and following the Echo testing. This wil be done without interfering or affecting any aspect of the normal procedure. Standard Protocol will be used with standard test termination indications.
The Diagnostic stage will include analysis of the hyperQ signal, aiming to classify results as ischemic or non-ischemic.
The HyperQ data will be compared to DSE results which will be used as the "gold standard" for this study unless Angiography results are obtained.
An additional comparison evaluation will be performed to assess the advantage of the HyperQ results on the ST-changes results obtained from conventional ECG.In addition all recruited subjects will be followed for up to 12 months.During this period a phone call will be performed every 3 months to evaluate cardiac status, hospitalization and especially Angiography procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject referred to dobutamine stress Echocardiography
- •Subject signed informed consent
排除标准
- •Subjects with implantable Pacemakers or Defibrillators
- •Subjects with Wolff-Parkinson-White Syndrome
结局指标
主要结局
HyperQ Signal recorded during the DES Test
次要结局
- DES Outcome/ Angiography