December 14, 2015 — Heart Test Laboratories Inc. (HTL) announced the commencement of a clinical study, initiated by Mount Sinai Medical Center, New York, examining the MyoVista heart screening device. The clinical study is designed to further evaluate the MyoVista, which incorporates HTL’s patented technology for the early detection of heart disease. The study will assess the MyoVista indications for the identification of coronary arterial disease (CAD) as compared to computed tomographic coronary angiography (CTA) and myocardial dysfunction in patients without CAD as compared to echocardiography.
The lead investigator is Partho Sengupta, M.D., the director of cardiac ultrasound research and core lab, and an associate professor of medicine in cardiology at Mount Sinai’s Zena and Michael A. Wiener Cardiovascular Institute and the Marie-Josée and Henry R. Kravis Center for Cardiovascular Health. The clinical study is expected to enroll 200 patients and take between 12-24 months to complete.
Heart disease is the leading cause of death in the U.S., being responsible for 1 in every 4 deaths (approx. 600,000 per year U.S.). It is the leading cause of deaths worldwide, more than all cancers combined, and is the largest spend area in healthcare. Heart disease is known as the silent killer because most affected people do not know they have it (i.e. they are asymptomatic); more than half of patients find out through an adverse event (angina, heart attack or even death).
The “diagnostic gap” in heart disease today is non-invasive, low-cost screening to identify asymptomatic patients before an adverse event occurs. Existing electrocardiography (ECG) technology is generally not considered effective for use on asymptomatic patients. The U.S. Preventive Services Taskforce and other healthcare bodies around the world recommend against screening with resting or exercise ECG for the prediction of coronary heart disease (CHD) events in asymptomatic adults at low risk for CHD events.
The MyoVista provides two tests in one and is easy for physicians to use. By using standard 12-lead resting ECG protocols, the device provides an ECG test incorporating interpretive analysis, as well as easy-to-understand proprietary informatics that assist a physician in identifying heart disease at an early stage.
HTL believes the MyoVista will provide the opportunity for effective, low-cost testing for heart disease in primary care. This would enable physicians to have a valuable additional tool to assist in the process of determining referrals to a cardiologist.
It has a 15.6-inch high resolution touch screen and incorporates user features and functionality commonly associated with a tablet device which make it intuitive and easy to use, thereby reducing training time. Its proprietary informatics provide information to physicians that suggest ischemic and certain types of structural heart abnormalities. The MyoVista is ideally suited for use in both primary care and hospital environments.
For more information: www.hearttestlabs.com