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Multi-Center Clinical Study Demonstrates HeartTrends Improves Early Detection for Heart Disease in Healthy Individuals

Study Presented at AHA’s 2019 Conference Shows Improved Detection of Myocardial Ischemia Versus Traditional Methods and Validates New Cardiac Risk Factor

Lev El Diagnostics of Heart Diseases Ltd. (Lev-El), a Jerusalem based privately held biomedical company specializing in non-invasive cardiovascular disease detection based on patented, machine learning AI algorithms, announced the results of the world’s largest prospective multi-center clinical study to evaluate the correlation between heart rate variability (HRV) and the presence of myocardial ischemia in healthy individuals without known coronary artery disease (CAD) that will be presented at The American Heart Association’s (AHA) 2019 Annual Scientific Sessions. The collaborative Mayo Clinic – Sheba study demonstrated that HeartTrends‘ HRV analysis improves early myocardial ischemia detection compared to both traditional cardiovascular risk factors and commonly used treadmill stress testing. Additionally, the study results validate a new and independent cardiac risk factor, enhancing current factors, which include: smoking, obesity, high blood pressure and/or cholesterol.

“Early detection of ischemia can now be offered to 80% of the global population – a significant increase over technology that detects AFib, a condition relevant to only 2% of the world. HeartTrends offers a time-efficient, easy-to-use and cost-effective early-detection stress test – involving no physical stress – that can be installed on wearable smart-devices,” said Dr. Dov Rubin, CEO of Lev-El Diagnostics, developers of HeartTrends. “We are excited about the opportunity to usher in the next step in digital health – beyond simple step and heart beat counting — for the detection of myocardial ischemia using wearable smart-devices.”

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Utilizing dynamic machine learning, HeartTrends technology can easily be implemented on any device capable of accurately recording 20 minutes of heartbeats. This time- and cost-effective test significantly increases global reach, bringing preventative cardiac stress testing to more people and communities and, in particular, can help with tests for the elderly, impaired or weight challenged. Importantly, the software offers cost-saving benefits for health insurers and represents another technological advancement in the wearable smart-device market all while ensuring user privacy.

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“This study introduces a sensitive, non-invasive test for the early detection of subclinical or early ischemia in individuals with low-to-intermediate pre-test probability for CAD, providing an incremental risk assessment and re-stratification tool for physicians,” said the study’s Principle Investigator, Prof. Ilan Goldenberg MD, Director of Clinical Cardiovascular Research at the University of Rochester Medical Center.

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The clinical study evaluated the association of HeartTrends HRV to the presence of myocardial ischemia in 1,043 individuals without known existence of CAD. After proving HeartTrends HRV scores provide higher sensitivity for CAD indicators than exercise stress testing in 2015, HeartTrends now confirmed that the addition of their algorithm to conventional CAD risk assessment provides timelier detection and an opportunity for earlier intervention in people with subclinical or early ischemia.

Co-researcher on the study, and Professor of Medicine and Cardiology at the Mayo Clinic, Dr. Bruce Johnson, said “This non-invasive application of HRV is an important prognostic tool in cardiology. In the era of wearable digital monitoring devices and increased interest in personalized approaches to health risk assessments, HeartTrends has the ability to provide useful data to identify individuals at risk for coronary artery disease and the monitoring of general health.”

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