ST. LOUIS, M.O.; NEW HAVEN, C.T., June 13, 2019 – The PROactive evaluation of function to Avoid Cardio-Toxicity (PROACT; NCT03862131) clinical trial has started at Washington University School of Medicine and Yale New Haven Hospital with patients receiving baseline MyoStrain® exams before chemotherapy treatment. The study will evaluate the ability of MyoStrain to predict patient cardiac risk during chemotherapy, assist in the early detection of cardiotoxicity and manage cardioprotective drugs during chemotherapy. The study will include 60 patients, consisting of breast cancer, lymphoma and sarcoma patients.
Participants of the PROACT will be classified into lower and higher risk groups based on their baseline MyoStrain results. The higher risk group will be randomized with half-blinded and half-unblinded to MyoStrain in terms of assessing cardiotoxicity incidence and management. Both the blinded and unblinded cohorts will receive follow-up MyoStrain exams at 1 month, 3 months, 6 months, 12 months, 24 months and 36 months after the baseline report. Physicians will have knowledge of the MyoStrain results in the unblinded group to augment standard of care in detecting and managing cardiotoxicity. Physicians will not have access to or knowledge of the MyoStrain results for patients in the blinded group.
Dr. Daniel Lenihan, the principal investigator for PROACT and Director of the Cardio-Oncology Center of Excellence at Washington University in St Louis, commented: “PROACT is a pivotal trial utilizing MyoStrain to detect cardiotoxicity related to cancer therapy at the earliest possible moment to allow the best cardio-protective therapy to be initiated. This study is expected to validate the use of MyoStrain for detecting cardiotoxicity and guiding cardio-protective treatments in order to ensure patients have healthy hearts at the end of their cancer treatment but still allowing the most effective cancer therapy to be delivered. MyoStrain is the first test that provides physicians with the inherent visibility to monitor the effects of cardiotoxicity from cancer therapy and promote the use of cardio-protective drugs on the heart. This is a game-changing technology that could revolutionize how we carefully monitor patients undergoing cancer treatment.”
Dr. Lauren Baldassarre, a Cardiologist at Yale New Haven Hospital and Assistant Professor at Yale School of Medicine, stated that “Yale is excited to be a part of the PROACT trial. MyoStrain is a promising technology to help ensure cardiac health in patients receiving potentially cardio-toxic cancer therapies.”
More information on the PROACT trial can be found here.
Myocardial Solutions, Inc. (MSI) is a medical technology company working to transform the cardiac and cancer care continuum. Leveraging more than 500 publications in clinical research and development, MSI’s proprietary technology, MyoStrain®, is a 10-minute, non-invasive MRI heart function test providing physicians with sensitive diagnostic markers to support the early assessment and individualized treatment of heart dysfunction. MyoStrain has received FDA-510(k) pre-market clearance, CE-mark certification, and is commercially available in the United States and Europe.
To learn more about MyoStrain, visit myocardialsolutions.com or connect with us on LinkedIn and Twitter @myocardialsoln.