Cleerly, a digital healthcare company focused on heart disease, has announced continued strong scientific evidence supporting the clinical utility of its products, detailing a study published online on Jan. 25, 2024 in the European Heart Journal Cardiovascular Imaging. Image courtesy: Cleerly
February 13, 2024 — Cleerly, a digital healthcare company focused on artificial intelligence (AI)-driven heart disease diagnosis, has announced continued strong scientific evidence supporting the clinical utility of its products, detailing a study published online on Jan. 25, 2024 in the European Heart Journal Cardiovascular Imaging1. The multi-center crossover study, “Impact of Atherosclerosis Imaging-Quantitative Computed Tomography on Diagnostic Certainty, Downstream Testing, Coronary Revascularization and Medical Therapy: The CERTAIN Study,” demonstrated the independent and strong incremental impact of Cleerly’s products in the prospective multicenter CERTAIN trial of 750 patients conducted at five sites in the United States.
Cleerly’s products were compared to the conventional standard of care interpretation of coronary CT angiography (CCTA) by expert level III imaging physicians. As compared to conventional CCTA interpretation alone, the use of Cleerly’s products led to a significant change in clinical decision making and patient management in more than 57% of patients, and increased physicians’ diagnostic confidence five-fold as compared with standard of care assessment of CCTA.
Use of Cleerly, which performs a comprehensive evaluation of coronary atherosclerosis (plaque), stenosis (narrowing) and ischemia (impaired blood flow), resulted in a 39% change in the assessment of coronary stenosis, a 37% reduction in the need for further invasive and non-invasive testing, and a 28% increase in the use of preventive medications, according to a written statement from Cleerly. It further reported that these results underscore the strong and positive effect of the Cleerly products on clinical utility for patients with suspected coronary artery disease.
“We are excited that our multicenter evidence supports what our rapidly growing customer base has been telling us for some time, namely, that use of Cleerly improves diagnostic accuracy and certainty, while reducing unnecessary downstream resource utilization and potentially harmful invasive testing, and increases the use of preventative medical therapy,” said James P. Earls, MD, Chief Medical Officer of Cleerly.
According to the company, Earls is a leader within the field of radiology and specializes in applications of advanced imaging technologies in cardiovascular care. He is a Professor of Radiology and prior to joining Cleerly full-time, served as Vice-Chairman of Radiology at George Washington University (GWU) Hospital in Washington, DC. Previous to GWU, Earls served as Medical Director and Vice President at Fairfax Radiological Consultants (FRC) in Fairfax, VA, where he was an early innovator and clinical adopter of coronary CT angiography. His seminal work proving the effectiveness of prospective ecg-gating to lower radiation dose is now used as the standard imaging technique world-wide. Earls has served as a member of the Board of Directors for the International Society of Magnetic Resonance in Medicine (ISMRM), the North American Society of Cardiac Imaging (NASCI), and the Society of Cardiovascular Computed Tomography (SCCT). He is the author of over 150 articles, book chapters, abstracts and other publications on advanced imaging technologies. Earls is a founding member and one of the first Fellows of the Society of Cardiovascular CT.
In all multicenter and single clinical studies performed to date, Cleerly’s products have consistently demonstrated robust clinical utility, including higher diagnostic accuracy and stronger prognostic risk stratification over such historical tests as nuclear SPECT stress testing and FFRCT.2-7
Through its FDA-cleared solutions driven by artificial intelligence, Cleerly, founded in 2017, supports comprehensive phenotyping of coronary artery disease, as determined from advanced non-invasive CT imaging. The company reports that its clinically-proven, AI-based digital care platform works with coronary computed tomography angiography (CCTA) imaging to help clinicians precisely identify and define atherosclerosis earlier, enabling them to provide personalized, life-saving treatment plans for all patients throughout their care continuum. It further notes that its 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 and is led by a world-class clinical and technical team.
More information: www.cleerlyhealth.com
References:
1 Nurmohamed N, Cole J, Budoff M et al Impact of Atherosclerosis Imaging-Quantitative Computed Tomography on Diagnostic Certainty, Downstream Testing, Coronary Revascularization and Medical Therapy: The CERTAIN Study. In Press European Heart Journal CV Imag 2024.This study was sponsored by Cleerly, Inc. and journal article authors Udo Hoffman, M.D., James Min, M.D. and James Earls, M.D. are employees of Cleerly, Inc.
2 Nurmohamed NS, Danad I, Jukema R. High Diagnostic Accuracy Of AI-Ischemia in Comparison To PET, FFR-CT, SPECT, and Invasive FFR: A PACIFIC Sub-Study. Presented at the American College of Cardiology Annual Scientific Meeting New Orleans LA 2023.
3 van Rosendael A, Danad I, CREDENCE study group, PACIFIC study group. Derivation, Validation and Prognostic Assessment of an AI-Based Algorithm for Determination of Coronary Ischemia: The CREDENCE and PACIFIC Trial. Presented at the European Association of Cardiovascular Imaging: Late Breaking Clinical Research and Trials. 2023. Barcelona, Spain.
4 Chiou A, Hermel M, Miller G et al. Cleerly® Vs. Heartflow® vs. Site Read in The Per-Vessel Prediction of Adenosine FFR ≤0.80 With Plaque Features Associated with False Positives. Presented at the American College of Cardiology Annual Scientific Meeting New Orleans LA 2023
5 Karlsberg RP, Gonzalez Quesada C, Samuels B et al. High diagnostic accuracy of a novel artificial intelligence guided quantitative coronary computed tomography algorithm for predicting myocardial ischemia. Presented at the Society of Cardiovascular Computed Tomography Annual Scientific Meeting Boston MA 2023. Journal of Cardiovascular Computed Tomography Vol. 17 Issue 4 Supplement S28–S29 Published in issue: July, 2023
6 Lipkin I, Telluri A, Kim Y, et al. Coronary CTA With AI-QCT Interpretation: Comparison With Myocardial Perfusion Imaging for Detection of Obstructive Stenosis Using Invasive Angiography as Reference Standard. AJR Am J Roentgenol 2022 Sep;219(3):407-419.
7 Bär S, Nabeta T, Maaniitty T. Prognostic Value of a Novel Artificial Intelligence-Based Coronary Computed Tomography Angiography-Derived Ischemia Algorithm for Patients with Suspected Coronary Artery Disease. Eur Heart J Cardiovasc Imaging. 2023 Dec 12:jead339. Epub ahead of print. PMID: 38084894.
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