Characterization of Ischemia Related Changes in Esophageal Electrocardiography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- ST-segment-elevation/depression in the ECG at J-point and 80ms later
研究概览
简要总结
Esophageal electrocardiography (eECG) has important advantages compared to standard ECG recordings.
Coronary artery disease leading to myocardial ischemia is very common and has potentially severe consequences for patients. To date, the investigators don't know the influence of ischemia on the eECG. The goal of the present study is to assess ischemic changes of the eECG induced by balloon occlusion of coronary arteries in patients undergoing coronary angiography.
详细描述
Background
Heart rhythm disorders frequently occur in the general population and potentially have serious consequences. Atrial fibrillation, the most common atrial arrhythmia, can lead to intracardiac blood clot formation an subsequent embolisation. Esophageal electrocardiography (eECG) provides detailed information about the electrical activity of the atria. Due to the good signal quality, eECG is a promising technique for rhythm monitoring.
Patients undergoing rhythm monitoring may also show signs of other cardiac diseases, particularly coronary artery disease (CAD) due to its high prevalence. It is therefore mandatory to define the ischemic changes in the esophageal ECG.
In CAD atherosclerotic processes narrow the lumen of coronary arteries and may cause exercise-induced ischemia (stable CAD). More importantly, there is also the risk of plaque rupture and subsequent blood clot formation. This cascade can lead to total occlusion of the coronary vessel and myocardial infarction.
Coronary angiography is used to determine the severity of coronary artery stenosis. This simple approach turned out to be useful in clinical routine. However, presence or absence of coronary collaterals is one of the reasons why coronary angiography alone may fail to define the clinical relevance of CAD. Collateral vessels as natural bypasses can grow and act as "backup" blood supply of the myocardial area at risk and can therefore reduce infarct size. The coronary wedge-pressure method is recognized as the scientific and clinical gold standard. Collateralization is an important confounder which also can "mask" ischemic changes on the ECG.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients referred for elective coronary angiography
- •Age >/= 18 years
- •Written informed consent to participate to this study
- •Exclusion Criteria
- •Seve mitral- or aortic valve disease
- •Acute coronary infarction
- •Known bleeding diathesis
- •Systolic blood pressure >200mmHg
- •History of operations of the esophagus
- •Active disease of the upper respiratory and gastroesophageal tract
- •Radiofrequency ablation of atrial fibrillation, less than six weeks ago
- •Right and left bundle branch block
- •Significant Q-waves in the surface leads as indicators for prior myocardial infarction
- •Pregnancy
排除标准
- 未提供
结局指标
主要结局
ST-segment-elevation/depression in the ECG at J-point and 80ms later
时间窗: 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 and 120 seconds after start of vessel occlusion
次要结局
- Increase/decrease of T-wave amplitude(0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 and 120 seconds after start of vessel occlusion)
- Relative ST-segment-elevation/depression(0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 and 120 seconds after start of vessel occlusion)
- Sensitivity and specificity of the esophageal electrocardiogram detecting ischemic conditions (using the intracoronary ecg as gold standard)(at the end of occlusion, expected on average to be 60 seconds)
- New U-wave(during the whole occlusion time, expected on average to be 60 seconds)
- beat-to-beat alternans of the ST-segment(during the whole occlusion time, expected on average to be 60 seconds)