Coronary Artery Disease Clinical Trial
Official title:
Characterization of Ischemia Related Changes in Esophageal Electrocardiography
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.
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.
The surface ECG of an important portion of patients undergoing arrhythmia screening also
shows signs of myocardial ischemia due to CAD or left ventricular hypertrophy. As with the
surface ECG, it is conceivable that ischemic changes occur in the eECG. The characterization
of ischemia related changes in eECG is crucial in order to guarantee the proper
classification of eECG events. To date, the characterization of such changes is not adequate
in order to allow the reliable clinical interpretation of eECG changes.
Objective
- To characterize changes in the esophageal ECG induced by myocardial ischemia due to
short-time coronary occlusion.
- To determine the influence of coronary collateral vessels on these changes.
Methods
Patients referred for elective coronary angiography will be randomized to four groups:
1. Patients undergoing temporary myocardial ischemia produced by a one-minute balloon
occlusion of the proximal left anterior descending (LAD) coronary artery.
2. Patients undergoing temporary myocardial ischemia produced by a one-minute balloon
occlusion of the proximal left circumflex artery.
3. Patients undergoing temporary myocardial ischemia produced by a one-minute balloon
occlusion of the proximal right coronary artery.
4. Patients undergoing temporary ischemia produced by a one-minute occlusion of the target
vessel (the vessel which shows a significant stenosis and accordingly requires a
therapeutical intervention).
During the occlusion, collateral flow indexes will be calculated. Simultaneously, surface
ECG, esophageal ECG and intracoronary ECG will be registered.
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