02 July 2014

Electrocardiogram (ECG) and its significance in Clinical trials

Electrocardiogram is a non-invasive and painless test used to record electrical impulses of the heart. To measure the electrical activity of the heart, electrodes will be attached onto the skin and a device external to the body records the activity. Apart from measuring the electrical activity of the heart, electrocardiogram can also measure the position and size of the heart chambers as well as if any damage to the heart is present and therefore this test is also used for drug trials.

There are two phases in each cardiac cycle or heart beat, contraction and relaxation. When the two ventricles relax the atria contracts and when the atria relax, the ventricles contract. The contraction is called as systole and the relaxation is called as diastole. Thus the two phases constitute a systole and diastole of both ventricles and articles. A system of nerve fibers controls the filling up and emptying of the heart chambers. This system of nerve fibers supply electrical stimulus to spark the contraction of the heart muscle.

Alterations in the electrical system of the heart may cause serious or life threatening consequences. In such a situation, the heartbeat can be regulated by implanting an artificial pacemaker. The sinoatrial and atrioventricular nodes act as the natural pacemakers of the heart. In an electrocardiogram test, problems with the heart rhythms and the conduction of heartbeat, can be recorded and produced on a paper. These parameters are measured as it can reveal if the heart is affected by an underlying heart condition or heart disease. Performing electrocardiogram depends on what is being measured. The test is in most cases performed when the patient is resting. The test can also be done while the patient is on an exercise bike or treadmill, done usually if the patient displays symptoms that relate to coronary heart disease.

Electrocardiogram test is used in case of symptoms such as difficulty in breathing, chest pain, angina, palpitations or abnormal heartbeats. Electrocardiogram helps to indentify if the patient has coronary artery disease. It also helps to identify if there is thickening of heart muscle.

To prepare for the test, the health care provider should be informed about the medication the patient is taking, as there are chances that these medications may interfere with the results. Drinking cold water immediately before taking electrocardiogram test may lead to false results.

When electrodes are first applied, it may feel cold. Some people could develop  rash or irritation where the electrode patches are attached, but it is quite rare . Normal heart rate is 60 to 100 beats per minute and normal heart rhythm is consistent and even.

Abnormal electrocardiogram results might be a sign of arrhythmias, congenital heart defects, change in the amount of potassium and sodium in the blood, past or current heart attack, myocarditis, poor blood supply to the arteries of the heart, atrial fibrillation, heart failure and many more.

Electrocardiogram test is not risky, and since no electricity is sent through the electrodes there is no risk of shock. The condition being tested determines the accuracy of the electrocardiogram test. It is not a hard and fast rule that a heart problem has to show up on taking electrocardiogram test as some heart defects or problems may not lead to any specific changes in ECG.

In clinical trials this test may be used to examine the success of the drug treatment. Most of the times, the test is used for research or diagnostic purposes on human hearts. As new regulatory guidance have rapidly emerged and its global acceptance, cardiac safety has become the prime concern in any new drug development during the recent years.


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