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

CREDENCE and PACIFIC-1 study data demonstrate potential power of AI-QCT ISCHEMIA

DENVER – March 26, 2024 -- 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 on March 13, 2024. 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,^1-2 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). 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."

These study results come after Cleerly announced that its Cleerly ISCHEMIA software device is billable using the new Category I CPT^® code 75580.

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 non-invasive CT imaging. Cleerly’s approach is grounded in science, based on over 10 million images from over 40,000 patients gathered over a 15-year-period in landmark, multicenter clinical trials. 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: www.cleerlyhealth.com.

Cleerly Press Contact:

press@cleerlyhealth.com

Disclaimer:
Cleerly ISCHEMIA is an add-on software module to Cleerly Labs that determines the likely presence or absence of coronary vessel ischemia, with the thresholds equivalent to invasive FFR ≤0.80 vs. >0.80, respectively. This threshold was chosen in accordance with the American Heart Association / American College of Cardiology professional societal guidelines that advocate for the use of FFR ranges at the 0.80 level to be used to guide clinical decision making for determining appropriateness of coronary revascularization.³ The diagnostic performance of Cleerly ISCHEMIA for non-invasive determination of the functional significance of CAD has been validated against direct invasive measurement of FFR.²

Cleerly ISCHEMIA prediction is based on coronary lesion morphology and plaque characteristics from CCTA imaging. It is a clinical decision support tool that should be used with the entirety of relevant patient specific data when making a diagnosis or clinical decision.

References:

1. Nurmohamed NS, Danad I, Jukema RA, et al. High Diagnostic Accuracy of AI-ISCHEMIA in Comparison to PET, FFR-CT, SPECT, and Invasive FFR: A Pacific Substudy. J Am Coll Cardiol. 2023 Mar, 81 (8_Supplement) 1362.
2. Nurmohamed NS, Danad I, Jukema RA, et al. Development and Validation of a Quantitative Coronary CT Angiography Model for Diagnosis of Vessel-Specific Coronary Ischemia. JACC Cardiovasc Imaging. 2024 Feb 29:S1936-878X(24)00039-1. doi: 10.1016/j.jcmg.2024.01.007. Epub ahead of print. PMID: 38483420.
3. Gulati M, Levy PD, Mukherjee D, et al. 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2021 Nov 30;144(22):e368-e454.

Disclosures:
This study was sponsored by Cleerly, Inc. and journal article authors Hao Wang MS; Chung Chan, PhD; Tami Crabtree, MS; Melissa Aquino, MS; James K. Min, MD; and James P. Earls, MD are employees of Cleerly, Inc.

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