HeartFlow Announces Enrollment of First Two Patients in REVEALPLAQUE Trial

Trial to evaluate new technology that may help physicians prevent heart attacks in patients

REDWOOD CITY, Calif., Oct. 14, 2021 (GLOBE NEWSWIRE) -- HeartFlow, Inc., the leader in revolutionizing precision heart care, today announced the commencement of the REVEALPLAQUE (A pRospEctiVe, multicEnter study to AnaLyze PLAQUE using CCTA) trial to evaluate HeartFlow’s non-invasive plaque technology, an automated, deep learning-based method for identifying, characterizing and segmenting plaque in the coronary arteries. The first two patients were enrolled at Bryan Heart in Lincoln, Nebraska by Brock Cookman, DO, MSA, FACC, FSCAI, Interventional Cardiologist, and Clyde R. Meckel, MD, FACC, FSCAI, Interventional Cardiologist.

Heart attacks are the most common cause of death for both men and women, yet 4 out of 5 deaths are preventable with lifestyle and nutrition changes if patients who are at high risk of a heart attack are identified early.¹ Understanding plaque burden – where plaque is in the coronary arteries, the amount of plaque and the type of plaque – is one of the best ways for physicians to identify patients at high risk of death from a heart attack.²

“For most patients, heart attacks happen without any warning symptoms. It is clear, however, that coronary plaque is the driving force behind understanding a patient’s risk of having a heart attack,” said Dr. Meckel, lead Principal Investigator for REVEALPLAQUE at Bryan Heart. “The tools available today for understanding plaque burden tend to be cumbersome or provide inconsistent results. To be able to accurately and non-invasively understand a patient’s plaque burden would be game changing in physicians’ abilities to save a patient’s life from a heart attack.”

The REVEALPLAQUE trial is planned to enroll 250 patients with stable coronary artery disease from approximately 15 sites across the U.S. and Japan. The primary endpoint of the trial is the level of agreement across total plaque volume and the characteristics of plaque as measured by the non-invasive HeartFlow plaque technology compared to intravascular ultrasound (IVUS) imaging, which is considered the standard for obtaining information about plaque burden.³ Other endpoints to be measured include percent plaque volume, calcified plaque volume, low attenuation plaque volume, and fibrous plaque volume. The US Lead principal investigators of the trial are Dr. Thomas Stuckey, Cone Health, North Carolina, and Dr. Jagat Narula, Mount Sinai Hospital, New York; and the Japan lead principal investigator is Dr. Gaku Nakazawa, Kindai University, Japan.