Wednesday, June 4, 2025

Cleerly® ISCHEMIA™ Demonstrates Robust Diagnostic Accuracy and Prognostic Utility in Analyses from Large Scale Clinical Trials

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Cleerly, the company on a mission to create a new standard of care to aid in the diagnosis of heart disease, shared findings from a study published online in the Journal of the American College of Cardiology: Cardiovascular Imaging. The study describes the validation of Cleerly’s artificial intelligence-guided quantitative coronary CT angiography (AI-QCT) ISCHEMIA technology for diagnostic accuracy and prognostic risk stratification

In two trials, the CREDENCE and PACIFIC-1 studies comprised a total of 513 patients who underwent coronary CT angiography, myocardial perfusion imaging with single photon emission CT (SPECT), and fractional flow reserve derived from CT (FFRCT).

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For patients with an abnormal Cleerly AI-QCT ISCHEMIA finding, a positive result was associated with an approximately 7-fold increase of adverse cardiovascular events during an 8-year follow-up. Collectively, this study shows that Cleerly AI-QCT ISCHEMIA, when used in conjunction with Cleerly LABS, can provide a 3-in-1 approach for the assessment of atherosclerosis, stenosis and ischemia.

“This pivotal study was performed in two different international populations which shows that CCTA analyzed with the Cleerly AI-QCT ISCHEMIA device provides an accurate assessment of coronary ischemia,” said James P. Earls, MD, Chief Medical Officer of Cleerly. “These promising findings offer the possibility of a novel care paradigm for symptomatic coronary artery disease evaluation that performs comprehensive analysis of atherosclerosis, stenosis and ischemia from a single non-invasive CCTA test, which may offer the benefit of guiding clinical decision making for both coronary revascularization and medical therapy.”

SOURCE: BusinessWire

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