Digital healthcare company Cleerly has announced that positive data from two studies investigating its AI-QCT ISCHEMIA software device has been published. 

Cleerly’s ISCHEMIA software device is an AI-powered tool that uses quantitative coronary computed tomography (QCT) angiography to diagnose coronary ischemia, a condition where there is reduced blood flow to the heart due to narrowed or blocked coronary arteries.

The device uses AI to analyse atherosclerosis and blood vessel shapes from patients’ coronary computed tomography angiography (CCTA) images. 

The data, published in the Journal of the American College of Cardiology: Cardiovascular Imaging, is from two studies, CREDENCE (NCT02173275) and PACIFIC-1 (NCT01521468). The tool was developed and tested on patients with suspected stable coronary artery disease who underwent various heart imaging tests.  

In the studies, the AI-QCT ISCHEMIA model showed strong diagnostic accuracy with AUC (area under the curve) values of 0.80 in the CREDENCE validation cohort and 0.85 in the PACIFIC-1 cohort. It outperformed other methods such as fractional flow reserve by CT (FFRcT), myocardial perfusion imaging (MPI), and positron emission tomography (PET). A positive result from the software was associated with a significantly higher risk of major adverse cardiovascular events (MACE).  

Cleerly’s US Food and Drug Administration (FDA)-cleared technology comprises more than two dozen AI and machine learning algorithms. These were designed to recognise signs of heart disease based on more than ten million images from over 40,000 patients gathered during landmark, multi-centre clinical trials in a 15-year period. 

When used in conjunction with Cleerly's LABS software, AI-QCT ISCHEMIA can assess for atherosclerosis, stenosis and ischemia, as per the 26 March press release. 

In the announcement accompanying the data, Cleerly’s chief medical officer James Earls said: “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 revascularisation and medical therapy." 

In 2021, Cleerly teamed up with Canon Medical to integrate Canon’s AI-based CT technology with Cleerly’s digital pathway solution to evaluate coronary artery disease.