Cleerly reports that PARAMOUNT met its primary endpoint, the first randomized trial comparing care guided by AI quantitative coronary CT angiography (AI-QCT) with the usual stress-testing route for patients presenting with chest pain. Results came as late-breaking science at the American Heart Association Scientific Sessions 2026 in Chicago and released November 7, with peer-reviewed publication expected in early 2027.
The Denver company says AI-guided care sharpened diagnostic certainty and moved substantially more patients onto lipid-lowering therapy than functional testing did.
What the trial measured
PARAMOUNT enrolled 530 symptomatic outpatients with suspected coronary artery disease, LDL cholesterol at or above 100 mg/dL, and no prior CAD history, across 21 sites from January 2025 through February 2026. The analysis rests on 523 participants whose data was locked at cutoff.
Half received plaque-based care guided by AI-QCT, which quantifies plaque burden and derives plaque-based ischemia. The other half received usual care based on functional stress testing.
Fewer needless cath lab trips
Among patients sent to the catheterization lab, plaque-based care yielded significantly fewer cases without obstructive disease, while overall rates of catheterization and revascularization did not climb.
Co-principal investigator Todd Villines, a cardiology professor at the University of Virginia, described the shift. For decades, he said, chest pain was evaluated by hunting for blockages or reduced flow, and PARAMOUNT indicates that measuring plaque directly and letting it steer care gives physicians clearer answers.
Women accounted for 57 percent of participants, an uncommon majority in cardiovascular research, with a median age of 57 and median baseline LDL cholesterol of 127 mg/dL. Udo Hoffmann, Cleerly’s chief medical, scientific and AI officer, said the trial shows how the approach supports diagnosing, staging and treating CAD.
