Clinical Evidence for
Personalized Heart Attack Prevention

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Personalized Cardiac Care Through Science-Based Plaque Analysis

Dr. Andrew Freeman, Director of Cardiovascular Prevention and Wellness at National Jewish Health, and Cleerly founder Dr. James K. Min discuss addressing the root cause of heart disease and personalizing care through science-based plaque analysis.

 

The Basis for AI-Enabled Heart Care

Coronary artery disease (CAD) represents the leading cause of morbidity and mortality in the world. Cleerly is an AI-enabled coronary computed tomography angiography (CCTA) analysis that uses detailed reporting to show providers where plaque and stenosis exists in coronary arteries. Cleerly’s approach is grounded in science, based on over 10 million images from over 40,000 patients gathered over a 15-year-period.

Data from six, discrete multi-center clinical trials have validated Cleerly as one of the most accurate approaches for identification, quantification and characterization of CAD. These trials show that Cleerly has superior accuracy against every current, clinical gold standard.

The accuracy of Cleerly’s reporting has also shown to reduce unnecessary, costly or invasive diagnostic methods. This aspect of Cleerly, combined with clinical insights that enable providers to personalize treatment for each patient, ultimately improves patient care and simplifies the tracking of plaque development, plaque calcification, and heart disease over time.

Cleerly Labs - AI-Enabled Heart Attack Prevention Analysis
 

How Cleerly Compares to Current Heart Disease Testing Methods

Cleerly vs. Level 3 Board Certified Expert Readers


For severe stenosis >70%, AI-QCT performance was excellent for measures of accuracy, sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV)
Accuracy 99.7%
Clinical Evidence - Cleerly vs Level III Readers
 
Sensitivity 90.9%
Specificity 99.8%
PPV 93.3%
NPV 99.9%

Cleery is superior to the consensus of Level 3 Expert Readers in determining stenosis severity, plaque volume and composition.1

Cleerly vs. Quantitative Coronary Angiography (QCA)



Per-patient AI-QCT performance for severe stenosis >70%
Accuracy 86% In cases where quantitative invasive angiography and AI-QCT disagreed, Ai-QCT exhibited higher agreement with invasive FFR for coronary ischemia, with more than 2/3 vessels considered ischemic by invasive FFR.


Clinical Evidence - Cleerly vs Quantitative Coronary Angiography
Sensitivity 94%
Specificity 82%
PPV 69%
NPV 97%

Cleerly demonstrates high diagnostic performance for determining stenosis severity.2

Cleerly vs. Myocardial Perfusion Imaging


Clinical Evidence - Cleerly versus MPI

Cleerly demonstrates higher diagnostic performance than myocardial perfusion imaging (MPI) for detecting obstructive CAD.3

Cleerly vs. Intravascular Ultrasound


Metric Correlation Clinical Evidence - Cleerly vs Intravascular Ultrasound (IVUS)
Vessel Area (mm2) 0.63
Lumen Area (mm2) 0.43
Plaque Area (mm2) 0.52
MLA per artery (mm2) 0.67

Cleerly demonstrates high agreement with intravascular ultrasound (IVUS) for absolute measures of coronary lumen size to determine accurate stenoses measurements.4

Cleerly vs. Near Field Infrared Spectroscopy


Variable Correlation Clinical Evidence - Cleerly vs Near Field Infrared Spectroscopy (NIRS)
Accuracy 95%
Sensitivity 93%
Specificity 94%
Positive Predictive Value 81%
Negative Predictive Value 98%

Cleerly demonstrates high agreement with near field infrared spectroscopy (NIRS) for the identification of lipid-rich plaques.5

Cleerly Reduces Expensive and Invasive Testing Methods

Coronary computed tomography angiography (CCTA) is a noninvasive diagnostic method that is shown to be highly effective at identifying arterial plaque when used in tandem with Cleerly. This can make it an effective precursor to more invasive testing methods.

Cleerly can be used to identify the large majority of suspected CAD patients who can be managed safely with medical therapy and lifestyle modifications, as well as those who may require additional testing.

Cleerly Clinical Evidence - Identify CAD Patients
 

Compared with current techniques, Cleerly can help to reduce unnecessary and high-cost invasive coronary angiograms (ICA) above and beyond CCTA alone. In a clinical trial, when used as a gatekeeper to detect stenosis, Cleerly reduced the number of ICAs performed by 86%.6

Cleerly Clinical Evidence - Reduce Invasive Coronary Angiograms
 

Clinical Insights Guide Personalized Treatment
with Track Your Plaque™ Disease Tracking
Cleerly’s whole-heart CAD evaluation gives providers the clinical insights they need to individualize patient treatment decisions and monitor plaque progression.

— Clinically relevant plaque stages provide a framework for physicians to initiate, intensify or de-intensify lifestyle interventions and medical management of patients with CAD.7

— Evaluation of plaque, including low-density-non-calcified plaque, non-calcified plaque, and calcified plaque, helps physicians assess a patient’s risk above and beyond stenosis severity and aggregate plaque burden.8

— Comparative CCTAs with Cleerly's Track Your Plaque™ demonstrate the effectiveness of statins for phenotypic plaque transformation through preferentially accelerating the calcification of plaque and reducing high-risk plaque development.9

— CCTA demonstrates a 41% reduction in the rate of death and non-fatal heart attacks in patients with chest pain that receive a CCTA vs. patients that did not at 5 years.10

Clinical insights with Cleerly's whole-heart CAD evaluation
 

References:
1 CT Evaluation by Artificial Intelligence for Atherosclerosis, Stenosis and Vascular Morphology. Journal of Cardiovascular Computed Tomography. Published November 2022.
2 AI Evaluation of Stenosis on Coronary CT Angiography, Comparison with Quantitative Coronary Angiography and Fractional Flow Reserve. Journal of the American College of Cardiology. Published February 2022.
3 Coronary CTA with AI-ACT Interpretation: Comparison with Myocardial Perfusion Imaging for Detection of Obstructive Stenosis Using Invasive Angiography as Reference Standard. American Journal of Roentgenology. Published September 2022.
4 Comparison of Endothelial Shear Stress Computation Utilizing Non-invasive Coronary Computed Tomography Angiography vs Invasive Intravascular Ultrasound Imaging, Hakin D et al, JCCT In Press 2022.
5 Omori et al AHA 2022.
6 Yukim Kim et al. In Submission. ESC Imaging 2022.
7 Coronary CTA Plaque Volume Severity Stages According to Invasive Coronary Angiography and FFR. Journal of Cardiovascular Computed Tomography. Published March 2022.
8 Coronary Atherosclerotic Precursors of Acute Coronary Syndromes. Journal of the American College of Cardiology. Published June 2018.
9 Progression of Atherosclerotic Plaque DetermIned by Computed TomoGraphic Angiography Imaging [PARADIGM]. Journal of the American College of Cardiovascular Imaging. Last Updated 2018.
10 Coronary CT Angiography and 5-Year Risk of Myocardial Infarction. New England Journal of Medicine. Released September 2018.

 

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