Cleerly's TRANSFORM Trial Sends a Mobile CT Scanner Across the South to Reach Patients in Underserved Communities

Operated with Clear Heart and Lung, the unit enables patients in communities without cardiac CT to join TRANSFORM, a trial testing whether treatment guided by coronary artery disease staging prevents heart attacks

DENVER--(BUSINESS WIRE)--Cleerly, a leader in advanced cardiovascular imaging analysis, and Clear Heart and Lung Imaging, a leader in outpatient imaging care, have taken a cardiac-capable mobile CT scanner across the southern United States to expand access to cardiovascular research and enable communities and clinics to participate in Cleerly's TRANSFORM Trial. From July through September 2026, the CT scanner traveled through Arizona, Louisiana, Georgia, and Florida, bringing cardiovascular imaging and clinical trial access to communities with limited access to cardiac imaging.

The unit carries a dedicated cardiovascular CT machine that captures the heart in a single heartbeat at 140 mm coverage, producing high-quality images of the coronary arteries that permit accurate assessment of atherosclerotic burden. This enables staging of coronary artery disease (CAD) and treatment tailored to CAD Stage in those patients randomized to the interventional arm of TRANSFORM.

"Patients in underserved communities can face barriers to participating in clinical trials, which can limit the generalizability of trial results," said Udo Hoffmann, MD, MPH, Chief Medical, Scientific, and AI Officer of Cleerly. "The mobile CT scanner allows us to bring coronary CTA to clinics and patients who may otherwise have limited access to advanced imaging. This supports Cleerly’s mission to create a world without heart attacks everywhere through a diagnose, stage, and treat approach to CAD, and helps broaden the diversity and geographic representation of TRANSFORM participants."

“Clear Heart and Lung Imaging was founded on the belief that access to advanced cardiovascular imaging remains a challenge in America,” said Kim Mischo, founder of Clear Heart and Lung Imaging. “The Clear Heart Mobile helps expand access to cardiovascular imaging, particularly in underserved communities. We're honored to partner with the TRANSFORM trial team, and with CT Coachworks, who built us the perfect mobile solution. Together we're bringing advanced cardiac imaging directly to patients who may otherwise have limited access to care, and expanding who gets to take part in cardiovascular research.”

About the TRANSFORM trial

TRANSFORM is the only randomized, event-driven outcomes trial evaluating an AI-guided approach to staging and treating coronary artery disease in patients at increased risk for heart attacks. The trial is testing whether diagnosis, staging, and treatment of CAD, guided by Cleerly's investigational Coronary Artery Disease Staging System, reduces heart attacks and other cardiovascular events more effectively than care based on traditional risk factors alone. Cleerly's AI-QCT technology quantifies and characterizes coronary plaque at sub-millimeter resolution, and based on the quantitative assessment of plaque, stenosis, and ischemia burden, assigns a proprietary four-tier CAD staging system, which is the basis for how intensively patients are treated.

TRANSFORM is active at 125 sites across the US and aims to randomize participants who are eligible if they are men over 55 or women over 65 who have diabetes and are otherwise free of symptoms of cardiovascular disease. Primary results are anticipated in 2029.

TRANSFORM is led by study chair Deepak L. Bhatt, MD, MPH, MBA, FACC, FAHA, FESC, MSCAI of the Mount Sinai Fuster Heart Hospital, and co-chair David J. Maron, MD of Stanford University School of Medicine, and coordinated by Marc P. Bonaca, MD, MPH, FACC, FAHA at CPC Clinical Research.

To learn more about the TRANSFORM trial, visit TransformTrial.org. Full eligibility criteria and participating sites are listed at ClinicalTrials.gov under identifier NCT06112418. Learn more about Clear Heart and Lung Imaging’s technology and mission at ClearHeartAndLung.com.

About Cleerly

Cleerly is the company on a mission to eliminate heart attacks by creating a new standard of care for heart disease. Through its FDA-cleared solutions driven by artificial intelligence, Cleerly supports comprehensive phenotyping of coronary artery disease, as determined from advanced noninvasive CT imaging. Cleerly’s approach is grounded in science, based on millions of images from over 40,000 patients. Led by a world-class clinical and technical team, Cleerly enhances health literacy for each and every stakeholder in the coronary care pathway. For more information, please visit: cleerly.com.