Have you ever heard the phrase, “my heart skipped a beat” when someone talks about an exciting or startling moment? It’s possibly just as common as the medical condition the phrase describes – arrhythmia.
BioTel Research’s Chief Medical Officer, Polina Voloshko, MD, presented an educational webinar about Detecting Arrhythmias in Clinical Trials Using Electrocardiographic (ECG) Monitoring on April 16, 2019. In addition to discussing BioTel Research’s capabilities for “delivering the difference” as a cardiac core laboratory, Dr. Voloshko presented on atrial fibrillation and other arrhythmias, principles of event and continuous ECG monitoring, and factors to consider when designing clinical trials that assess arrhythmias through ECG monitoring.For those of you less familiar with cardiac safety, an arrhythmia occurs when the heart beats with an abnormal pattern, whether it beats too slowly (bradycardia), too quickly (tachycardia), but irregularly. Nearly everyone experiences some degree of an arrhythmia in their lifetime, varying from generally harmless to more problematic, and diagnosis can be challenging as arrhythmias can present with unnoticeable symptoms, be misdiagnosed for other conditions, or happen intermittently. Atrial fibrillation, the most common type of arrhythmia, refers to the heart beating irregularly in the upper chambers (the atria), causing less efficient blood flow to the lower chambers (the ventricles). When the condition goes unnoticed and/or untreated, there is increased risk of stroke, heart disease and heart failure, costing the United States over $6 billion each year and leading to fatal outcomes (CDC, 2017). Atrial fibrillation affects 2-6 million Americans each year and the prevalence is expected to double by 2050 (Morillo et al., 2017). Given this projection, it’s important for atrial fibrillation to be effectively managed. By using ECG monitoring devices, such as the ePatch offered by BioTel Research, otherwise undetected arrhythmias can be diagnosed and treated.
Deciding which ECG monitoring device suits the needs of your clinical trial can be a complicated process – there are so many things to consider. To make the process easier, Dr. Voloshko and our other global scientific consultants are ready to support you with your protocol development, data interpretation, expert reporting, centralization strategy, statistical analysis, regulatory agency assistance, and more!
Did you miss the webinar? Don't worry, you can now view it on-demand!
Centers for Disease Control and Prevention. (2017, August 22). Atrial Fibrillation Fact Sheet. Retrieved from https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_atrial_fibrillation.htm.
Morillo, C. A., Banerjee, A. B., Pablo, P., Wood, D., and Jouven, X. (2017). Atrial fibrillation: the current epidemic. Journal of Geriatric Cardiology, 14(3), 195-203. doi: 10.11909/j.issn.1671-5411.2017.03.011