An Artificial Intelligence-Guided Ultrasound Study

Bay Labs and Northwestern Medicine announced that the first patient has been enrolled in a first-of-its-kind study. The study will evaluate the use of Bay Labs' EchoGPS cardiac ultrasound guidance software to enable certified medical assistants (CMAs) as medical professionals with no prior scanning experience to capture high-quality echocardiograms. The study will also evaluate the use of its EchoMD measurement and interpretation software suite to detect certain types of heart disease among patients 65 years and older undergoing routine physical examinations in primary care settings.

"Deep learning will have a profound impact on cardiac imaging in the future, and the ability to simplify acquisition will be a tremendous advance to bring echocardiograms to the point-of-care in primary care offices," said Patrick M. McCarthy, MD, chief of cardiac surgery at Northwestern Memorial Hospital, executive director, Northwestern Medicine Bluhm Cardiovascular Institute and principal investigator on the project.

"SHAPE: Seeing the Heart with AI Powered Echo" is the first study to evaluate AI-guided ultrasound acquisition by CMA's. SHAPE is a non-randomized study which will enroll approximately 1,200 patients at Northwestern Medicine sites, including Northwestern Medicine Central DuPage Hospital and Northwestern Medicine Regional Medical Group primary care clinics. The primary objective of the study is to determine whether CMAs can use the Bay Labs' EchoGPS to obtain diagnostic quality echocardiograms, and if those images reviewed by cardiologists with the assistance of the EchoMD software suite will enable detection of more patients with cardiac disease in a primary care setting compared to standard physical examination with an electrocardiogram (ECG).

The SHAPE study is a part of Bay Labs' ongoing partnership with Northwestern Medicine to explore new ways to apply AI to clinical cardiovascular care and fits into Northwestern's larger AI initiative, which focuses on harnessing the power of AI to advance the study and treatment of cardiovascular disease. The AI initiative is funded, in part, by a $25 million gift from the Bluhm Family Charitable Foundation, formed by Neil G. Bluhm, a prominent Chicago philanthropist and real estate developer. For more details on the SHAPE study, including enrollment information, please visit Clinicaltrials.gov identifier #NCT03705650.

Bay Labs' EchoGPS is investigational software integrated into an ultrasound system. EchoGPS uses AI to aid in the acquisition of echocardiograms by providing non-specialist users real-time guidance to obtain cardiac views. The EchoMD software suite assists cardiologists in automated review of images captured. Bay Labs received FDA clearance for its first release of EchoMD in June 2018, which included AutoEF software that fully automates clip selection and calculation of left ventricular ejection fraction (EF), the leading measurement of cardiac function.

"The EchoGPS and EchoMD product suite has the potential to transform how cardiovascular care can be delivered in healthcare systems," said Charles Cadieu, co-founder and CEO of Bay Labs. "Incorporating our AI software with deep learning technology into clinical practice could allow non-specialist medical professionals to acquire images to support cardiologist interpretation and clinical decision-making and may lead to improved patient outcomes through earlier detection and monitoring."

Research shows that routine physical exams may miss detecting heart conditions, and older age is associated with greater risk of cardiovascular disease. According to the Centers for Disease Control and Prevention, over 600,000 people in the U.S. die from heart disease each year, making it the leading cause of death. Earlier detection of heart disease, using tools like echocardiography, may lead to more appropriate treatment for these patients. While echocardiography is a key tool in the diagnosis and management of heart disease, one reason it is typically not available in primary care settings is that it is presently performed by certified experts with years of specialized training. In contrast, CMAs work alongside physicians and are trained to perform a wide range of administrative and clinical duties, including taking patient medical histories and performing basic laboratory tests, but are not typically trained to perform ultrasound exams.

EurekAlert!, the online, global news service operated by AAAS, the science society: https://www.eurekalert.org/pub_releases/2018-11/nmh-bla111218.php