Identify Heart Disease Directly with Coronary Computed Tomography Angiography and AI-Analysis

Every 36 seconds, someone dies from heart disease in the United States. (1) Globally, that timeframe shortens to every 1.7 seconds. (2) As the leading cause of mortality and morbidity in the world, cardiovascular disease is responsible for 32% of all deaths. (3)

In light of these stark statistics, cardiovascular health care relies on indirect ways of identifying and monitoring heart disease. For example, providers measure surrogate markers of health, such as blood pressure and cholesterol. Upon signs of coronary artery disease (CAD), patients perform stress tests, which monitor heart rate, blood pressure and breathing. Furthermore, care typically begins after a patient presents with symptoms, when, in reality, patients considered low risk experience the majority of heart attacks.

Cleerly, a team dedicated to eradicating heart disease, shifts the field’s focus to direct measurements of the primary disease: atherosclerosis. The specific plaque type, more than any other characteristic, informs risk for future heart attack.

Cleerly Labs Coronary Report

Identifying Disease With Coronary Computed Tomography Angiography

Cancer prevention relies on advanced imaging tools, such as mammography, colonoscopy, and lung CT scans—why shouldn’t heart disease prevention do the same? Cleerly believes cardiology can emulate the successes seen in cancer screening by applying the same approach to prevent heart attacks. Providers shouldn’t have to wait for patients to present with chest pain, potentially indicating late-stage disease, before treating them.

As of 2021, coronary computed tomography angiography (CCTA) has been recommended by the American College of Cardiology (ACC) and the American Heart Association (AHA) as a first-line evaluation for patients with signs of heart disease. (4) CCTA identifies plaque buildup even in the absence of As of 2021, coronary computed tomography angiography (CCTA) has been recommended by the American College of Cardiology (ACC) and the American Heart Association (AHA) as a first-line evaluation for patients with signs of heart disease. (4) CCTA identifies plaque buildup even in the absence of artery narrowing, an important differentiator from noninvasive tests and invasive angiography. Cleerly employs this advanced, noninvasive imaging technique to measure atherosclerosis and facilitate disease-based care.

“I realized our field was asking the wrong question, and that all the tools and approaches we’ve used in cardiology leverage indirect markers of heart disease,” says James K. Min, MD, board-certified cardiologist and founder and CEO of Cleerly. “It sounds strange to say, but heart doctors have never actually measured heart disease.”

Dr. Min’s expertise in cardiovascular imaging and disease prevention led him to become director of the Dalio Institute of Cardiovascular Imaging at NewYork-Presbyterian Hospital. Dr. Min also formerly served as a professor of cardiovascular medicine and radiology at Weill Cornell Medical College before starting Cleerly.

“We are aiming to define a new standard of care for prevention of heart attacks,” says Dr. Min. “The fundamental advance that Cleerly offers is to provide personalized care so that we don’t miss an at-risk patient before we can properly treat them.”

The Novel Combination of CCTA and Artificial Intelligence

Cleerly has developed a precise evaluation of CCTA results run by artificial intelligence and machine learning. The program analyzes each coronary artery and branch, and classifies plaque buildup and type according to risk level. Given the exquisite sensitivity of AI, analysis shows high agreement with intravascular ultrasound on measures of lumen and plaque size. The results land in physicians’ hands just one hour later, at any time of the day or night.

Numerous studies reveal that Cleerly technology excels in several areas, including:

• Detection of CAD in 43-75% of patients missed by expert clinical readers (5,6)
• Discrimination of patients with acute coronary symptoms (7)
• Identification of high-risk plaques in 58% more patients than expert clinical readers (5)
• Reduction of invasive coronary angiograms by 55-77% (6)

Furthermore, Cleerly equips physicians and patients with the information they need stabilize high-risk plaques. Awareness of plaque type can prompt the necessary lifestyle changes and medical therapy to transform dark, high-risk plaques into calcified, stable plaques.

Cleerly’s Digital Care Pathway: From Identification to Disease Tracking

To seamlessly incorporate CCTA and AI analysis into current care, Dr. Min and colleagues have developed a comprehensive, five-part digital care pathway:

1. Identify: The whole-heart analysis program rapidly and accurately evaluates atherosclerosis given data from a Cleerly-enabled CCTA imaging location.
2. Define: AI analysis translates complex imaging science into actionable clinical insights. The web-based report shares heart disease diagnostics, including plaque analysis, vessel by vessel detail, and stenosis scoring, tailored to each provider who views the results.
3. Educate: A personalized report for patients communicates results and images with patient-friendly language. The report empowers patients to understand their amount and type of heart disease, and treatment plan to maintain heart health.
4. Treat: In partnership with ACC, Cleerly shares a series of “Treat Disease” algorithms based on AI-analysis. The algorithms support physicians in determining patient risk and offer insights to help guide clinical decision-making.
5. Track: Our program longitudinally tracks heart disease to prove treatment success or alert physicians of the need for additional intervention. Continued analysis provides quantitative tracking by monitoring plaque transformation over time.

“Through a CCTA-enabled disease-based approach, early quantification and characterization of heart disease will enable earlier and more effective treatment that can prevent heart attacks and death for millions of patients,” emphasizes Dr. Min. “If Cleerly can accomplish what we aim to do, we will disseminate our solutions globally and influence policies so that we can get the right patient the right treatment at the right time.”

References:

1. Centers for Disease Control and Prevention. Heart Disease Facts. Last reviewed February 7, 2022.
2. Centers for Disease Control and Prevention. Heart Disease in the United States. Accessed March 28, 2022.
3. World Health Organization. Cardiovascular Diseases (CVDs). Accessed March 28, 2022.
4. 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: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circ. 2021 Oct;144:368-454. doi: 10.1161/CIR.0000000000001030. Accessed 3/28/2022.
5. Choi AD, Marques H, Kumar V, Griffin WF, Rahban H, Karlsberg RP, Zeman RK, Katz RJ, Earls JP. CT Evaluation by Artificial Intelligence For Atherosclerosis, Stenosis and Vascular Morphology (CLARIFY): A Multi-center, international study. J Cardiovasc Comput Tomogr. 2021 Jun 12:S1934-5925(21)00081-2. doi: 10.1016/j.jcct.2021.05.004. Epub ahead of print. PMID: 34127407.
6. Yumin Kim, Anha Telluri, Isabella Lipkin, Andrew J. Bradley, et al, Selective Referral Using Artificial Intelligence Guided CCTA Versus Direct Referral for Individuals Referred to Invasive Coronary Angiography for Suspected Coronary Artery Disease: A CONSERVE Trial Sub-study. In-Submission Radiology AI 2021.
7. Bittner DO, Mayrhofer T, Puchner SB, Lu MT, Maurovich-Horvat P, Ghemigian K, Kitslaar PH, Broersen A, Bamberg F, Truong QA, Schlett CL, Hoffmann U, Ferencik M. Coronary Computed Tomography Angiography-Specific Definitions of High-Risk Plaque Features Improve Detection of Acute Coronary Syndrome. Circ Cardiovasc Imaging. 2018 Aug;11(8):e007657. doi: 10.1161/CIRCIMAGING.118.007657. PMID: 30354493; PMCID: PMC6205220.