HeartFlow’s Noninvasive Plaque Technology Will Be Evaluated in REVEALPLAQUE Trial

October 14, 2021—HeartFlow, Inc. announced the commencement of the REVEALPLAQUE trial to evaluate the company’s noninvasive plaque technology.

The HeartFlow plaque technology is an automated method that analyzes coronary CT scans to enable clinicians to visualize, characterize, and quantify plaque. The technology is currently available for investigational use only and is not available for commercial use, advised the company.

REVEALPLAQUE is a prospective, multicenter study to analyze plaque using coronary CT angiography.

According to the company, the REVEALPLAQUE trial is planned to enroll 250 patients with stable coronary artery disease at approximately 15 sites across the United States 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 noninvasive HeartFlow plaque technology compared to intravascular ultrasound imaging, which is the standard for obtaining information about plaque burden. Other endpoints to be measured include percent plaque volume, calcified plaque volume, low attenuation plaque volume, and fibrous plaque volume.

In the United States, the lead Principal Investigators of the trial are Thomas Stuckey, MD, at Cone Health in Greensboro, North Carolina, and Jagat Narula, MD, at Mount Sinai Hospital in New York, New York. In Japan, the lead Principal Investigator is Gaku Nakazawa, MD, at Kindai University in Osaka, Japan.

The first two patients in the REVEALPLAQUE trial were enrolled at Bryan Heart in Lincoln, Nebraska, by interventional cardiologists Brock Cookman, DO, and Clyde R. Meckel, MD. Dr. Meckel is lead Principal Investigator for REVEALPLAQUE at Bryan Heart.

“For most patients, heart attacks happen without any warning symptoms,” commented Dr. Meckel in HeartFlow’s press release. “It is clear, however, that coronary plaque is the driving force behind understanding a patient’s risk of having a heart attack.”

Dr. Meckel continued, “The tools available today for understanding plaque burden tend to be cumbersome or provide inconsistent results. To be able to accurately and noninvasively understand a patient’s plaque burden would be game changing in physicians' abilities to save a patient’s life from a heart attack.”

The company noted that the REVEALPLAQUE study builds upon HeartFlow’s EMERALD and EMERALD II trials. In the EMERALD trial exploring the mechanism of plaque rupture in acute coronary syndrome using coronary CT angiography and computational fluid dynamic, the HeartFlow technology incorporating both plaque features and physiology was able to accurately predict the high-risk plaques that were most likely to rupture and cause a heart attack. The EMERALD II trial is currently enrolling patients.