Cleerly® ISCHEMIA™ Solution for Heart Disease Analysis — FDA cleared, evidence-based AI and machine learning-based algorithm detects heart disease-associated ischemia. Read the full release.
Ischemia.
Reinvented.
Precision heart care at the nexus of vascular biology and artificial intelligence.
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Dr. Kern's Biography and Video Transcript
Morton J. Kern, MD, MSCAI, FACC, FAHA, is a professor of medicine at the University of California, Irvine, and former Chief of Cardiology and Chief of Medicine at the Long Beach Veterans Administration Medical Center. He practices interventional cardiology and teaches cardiology fellows cardiac catheterization and percutaneous coronary interventions.
Kern is the author of several major textbooks, including The Cardiac Catheterization Handbook, which is used nationally and internationally to train physicians in the subject, and published the second edition of the SCAI Interventional Cardiology Board Review.
His research interests include coronary physiology, hemodynamics, and invulnerable plaque.
Disclaimer
The views and opinions expressed in this presentation are solely those of Dr. Morton J. Kern and do not necessarily reflect the views or official policy of Cleerly. The information provided is intended for general informational and educational purposes only and should not be construed as medical advice, diagnosis, or treatment. Cleerly makes no representation or warranties regarding the accuracy or completeness of the information provided and disclaims any and all liability for errors or omissions.
Transcript
I think we've entered a time in the treatment of coronary artery disease (CAD) that moves well beyond routine stress testing and into our advanced assessment of the vessel, the wall, the myocardium and the potential for future risk in a noninvasive approach.
So in patients who are suspected of having ischemia due to coronary artery disease, we have a number of modalities to test for limited blood flow. Commonly used every day in every clinical practice around the world. And they are markers of limited blood flow in most circumstances. However, they have a high rate of false positives and a modestly high rate of false negatives. So they are not a standard that we can rely on 100%.
Computed tomography angiography (CTA) coupled with physiology, has become very important to the decision making before we come into the cath lab.
For several years there's been involvement of CT FFR generated through a number of mathematical models and provide us with anatomy and ischemia for that vessel and a map of the heart.
Cleerly has used another method to get that similar type of result. So we have the anatomy, we have an ischemic potential of that vessel, but we also have more features. It incorporates many more variables than any of our other tools and it comes out with a refined decision point for us. We can use the Cleerly tool to talk to us about anatomy and physiology, and have our answer in one test.
The role that artificial intelligence plays in the generation of the information that comes out of that Cleerly tool is unique in that it encompasses an entire array of variable inputs. It processes them, couples them with the information on the vessel wall, and information we get from CT and we get a refined response to ischemia.
We find out through this model that we're going to be able to predict ischemia. And it's not the AI itself, it's the net result of having all this available to us in an ischemia tool. Which make the risk in that individual more easily identified and result in an outcome, when tested through the Cleerly modality, that gives us some information we may not have through any of the other modalities.
When we look at some of the preliminary data and early studies with the Cleerly product, it looks like there is increased specificity with the method of Cleerly to give us risk of a major adverse event in our patients going forward. This is something that is not as strongly developed or available in other modalities.
The Cleerly method for looking at the CTA provides more information than almost any of the other CTAs do. And with that, we're able to look at different aspects of the vessel that would change the way we would treat it. And I think this makes the Cleerly product a potential game changer.
Cleerly ISCHEMIA is a first-of-its-kind, FDA-cleared heart disease evaluation that uses 37 measures of heart health to determine likelihood of coronary artery ischemia at a per-vessel level. Cleerly ISCHEMIA uses machine learning and concise reporting to aid physicians in personalizing patient treatment, including the planning of interventional treatments such as stent placement.
Informed Decision Making.
When used in conjunction with Cleerly LABS, Cleerly ISCHEMIA findings impacted and changed physician decision making in a majority of patients.6
Personalized Assessment.
By applying advanced AI to novel measurements of heart disease, Cleerly ISCHEMIA enables a modern approach to personalized heart disease assessment.
Clinical Validation
Cleerly ISCHEMIA’s ability to determine a likely invasive FFR was validated through multiple clinical trials with invasive FFR as the gold standard. Cleerly ISCHEMIA performed consistently well across all studies, having either outperformed or equivalent to other noninvasive measures of ischemia — specifically FFRCT, myocardial perfusion imaging (SPECT), and PET.1–5
ISCHEMIA. Reinvented.
Please fill out the form to download the Cleerly ISCHEMIA Clinical Validation review.
CREDENCE Trial
In the prospective, multicenter CREDENCE trial, Cleerly ISCHEMIA demonstrated higher diagnostic accuracy and area under the curve compared to FFRCT and stress testing, as referenced to 868 invasive measurements by fractional flow reserve (FFR), the ‘gold standard’ for determining ischemia.2
PACIFIC Trial
In a post-hoc analysis of the PACIFIC study, Cleerly ISCHEMIA was compared to FFRCT, 15O-H2O PET and SPECT to predict invasive FFR≤0.8 as reference standard. On a per-patient basis Cleerly ISCHEMIA, FFRCT and PET performed similarly and outperformed SPECT in predicting ischemia.2 Cleerly ISCHEMIA, using multivariate analysis, was the only non-invasive ischemia test that was prognostic of future MACE events, FFRCT and SPECT were not.2
"The Cleerly method for looking at the CTA provides more information than almost any of the other CTAs do. And with that, we're able to look at different aspects of the vessel that would change the way we would treat it. And I think this makes the Cleerly product a potential game changer."
Morton J. Kern, MD, MSCAI, FACC, FAHA
Interventional Cardiologist Professor of Medicine, University of California, Irvine
How Cleerly ISCHEMIA Works
A Cleerly ISCHEMIA Index (CII) is provided for all analyzable coronary vessels as a part of the Cleerly analysis. The CII indicates ischemia either being unlikely present or likely present based on the threshold equivalent to invasive fractional flow reserve (FFR) measures of >0.80 vs. ≤0.80, respectively. By integrating coronary atherosclerosis and vascular morphology characteristics into a single physiologic measure that identifies likely coronary ischemia, the Cleerly ISCHEMIA analysis provides actionable information to the physician to assess a patient's heart health.1–5
Clinical Workflow
Applying the Category I CPT® Code 75580 to Cleerly ISCHEMIA
Category 1 CPT® Code 75580: “Noninvasive estimate of coronary fractional flow reserve derived from augmentative software analysis of the data set from a coronary computed tomography angiography, with interpretation and report by a physician or other qualified healthcare professional.”
Cleerly ISCHEMIA is a novel, artificial intelligence-enabled method applied to typically acquired CCTA to determine ranges of FFR values that categorize a vessel’s likelihood of exhibiting ischemia. A physician or other qualified healthcare professional then assesses the data on a vessel by vessel level to determine what, if any, intervention is needed. The ability for Cleerly ISCHEMIA to provide this comprehensive lesion-by-lesion mapping within a vessel for the the clinically actionable features of coronary artery disease can be used to support the care team in determining whether there may be a lesion to be considered for coronary revascularization and if so, to guide the care team to such relevant factors as ischemia, stenosis and atherosclerosis.
Cleerly ISCHEMIA is billable under the CAT 1 CPT® Code 75580, as it meets the guidelines determined by the American Medical Association.
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Disclaimer
This communication is provided for informational purposes only and does not constitute a recommendation, representation, warranty, statement or guarantee by Cleerly, Inc. concerning appropriate coding or levels of payment for services rendered. This communication is not intended to increase, maximize, or otherwise adjust payment for the provider nor indicate coverage from any payor. Providers should consult with their reimbursement professional, as well as legal counsel, to ensure all legal and regulatory requirements have been met to support appropriate coding as required by payors for services rendered.
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References
1 Chiou, Andrew et al. “Artificial intelligence coronary computed tomography, coronary computed tomography angiography using fractional flow reserve, and physician visual interpretation in the per-vessel prediction of abnormal invasive adenosine fractional flow reserve.” European Heart Journal. Imaging methods and practice vol. 2,1 qyae035. 6 May. 2024, doi:10.1093/ehjimp/qyae035
2 Nurmohamed N, Danad I, Jukema R, et al. Development and validation of a quantitative coronary CT angiography model for diagnosis of vessel-specific coronary ischemia. In Press JACC CV Imaging. 2024.
3 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.
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 Nurmohamed NS, Cole J, Budoff M et al. Changes in CAD Diagnosis, Imaging, Intervention and Medication with AI-QCT: the CERTAIN trial. Presented at the Society of Cardiovascular Computed Tomography Annual Scientific Meeting Boston MA 2023. In Submission (invited) Circulation Cardiovascular Imaging. Journal of Cardiovascular Computed Tomography Vol. 17 Issue 4 Supplement S56–S57 Published in issue: July, 2023.
Cleerly ISCHEMIA is available by prescription only.
Request your Cleerly ISCHEMIA Demo
Contact us for a one-on-one software demonstration with a Cleerly expert to see how bringing Cleerly’s AI‑driven CCTA analysis to your organization can empower you to provide personalized treatment decisions for your patients.
Cleerly® ISCHEMIA™ analysis software is an automated machine learning-based decision support tool, indicated as a diagnostic aid for patients undergoing CT analysis using Cleerly® LABS™ software. When utilized by an interpreting healthcare provider, this software tool provides information that may be useful in detecting likely ischemia associated with coronary artery disease. Patient management decisions should not be made solely on the results of the Cleerly ISCHEMIA analysis. Rx Only.
Patents
Cleerly continues to revolutionize heart attack and cardiovascular disease prevention and treatment everyday by inventing world-class technology. Cleerly invests significant time and resources in research and development towards this goal. To protect Cleerly’s research and development efforts, Cleerly has vigorously developed a robust intellectual property portfolio – all part of a strategy for protecting the innovations that make Cleerly an industry leader in cardiovascular disease prevention and treatment.
Cleerly’s products and services may be covered by or for use under one or more of U.S. Patent Nos. 11,922,627, 11,948,301, 12,023,190, 11,861,833, 11,967,078, 11,832,982, 11,690,586, 11,779,292, 11,730,437, 11,672,497, 11,737,718, 11,751,826, 11,660,058, 11,896,415, 11,751,830, 11,751,829, 11,302,001, 11,308,617, 11,238,587, 11,302,002, 11,321,840, 11,341,644, 11,244,451, 11,288,799, 11,276,170, 11,210,786, 11,232,564, 11,367,190, 11,315,247, 11,969,280, 11,094,060, 11,120,550, 11,120,549, 11,132,796, 11,094,061, 11,113,811, 11,501,436, 11,751,831, 11,642,092, 11,759,161, 11,317,883, 11,350,899, 11,766,230, 11,766,229, and 10,813,612, as well as other patents that are pending.
For additional information, please contact legal@cleerlyhealth.com.