A personalized care pathway for heart attack prevention

Simply put, the current approach to cardiovascular care is flawed. Traditional methods fail to focus on the detection and to inform treatment of actual heart disease – known as atherosclerosis or measurement of arterial plaque – in favor of symptom-driven care. This fundamental lack of a disease-based care paradigm not only relies on indirect measures of heart disease, rather than heart disease itself, but often prevents personalized care plans that can support evaluation and treatment. The result is an approach that leaves far too many high-risk patients undiagnosed or beginning treatment too late, and others subjected to expensive, invasive, and unnecessary procedures.

Backed by nearly 20 years of clinical research and industry-leading AI technology, Cleerly’s personalized care pathway for heart attack prevention was built to address these issues. Cleerly’s methods focus on measuring, characterizing, and tracking atherosclerosis – instead of searching for indirect markers of heart disease. This approach is called precision heart care. With a methodology modeled after the way healthcare has addressed cancer and common chronic conditions for decades – this closed-loop approach leverages emerging technology to provide high-value, personalized, and precision cardiovascular care.

Identifying risk with comprehensive, whole-heart phenotyping
The first step in addressing heart disease is identifying atherosclerosis using comprehensive and accurate coronary artery disease (CAD) detection. To do this, Cleerly utilizes coronary computerized tomography angiography (CCTA)-based evaluation for atherosclerosis, which aligns with the American College of Cardiology’s raising CCTA to a Level 1A in its guidelines for chest pain evaluation. 

Unlike existing approaches that evaluate indirect markers or symptoms such as cholesterol or shortness of breath, Cleerly’s analysis delivers comprehensive coronary phenotyping of all coronary arteries and their branches, allowing for quantification of the strongest predictor of future heart attack risk.

CCTA uses advanced CT technology to determine the presence of plaque buildup in the arteries, as well as the amount and type of plaque. Compared to more traditional methods of evaluating heart disease, this process is more accurate and far less invasive. Cleerly’s published data from multi-centered clinical trials based on over 10 million images from over 40,000 patients gathered over a 15-year-period, have demonstrated high evaluationperformance compared to traditional methods. This includes expert (Level III) clinical readers, quantitative coronary angiography (QCA), fractional flow reserve (FFR), intravascular ultrasound (IVUS) and invasive near-field infrared spectroscopy (NIRS) for CAD evaluation. The ability to non-invasively enable direct visualization of actual heart disease early is the most critical step in reducing heart attack risk.

© Cleerly | https://cleerlyhealth.com

Translating advanced imaging science and data into actionable clinical insights
Cleerly’s Proxy software allows for the seamless transmission of data to care providers by automating the upload of CCTA scans from local systems to Cleerly’s cloud service. A single installation can be used as an endpoint to receive CCTA scans from one or more imaging modality, picture archiving and communication system (PACS) or vendor neutral archive (VNA) modalities. Each scan can then be uploaded into the Cleerly service for one or more providers to review and share results with patients.

The workflow solution is distributed as an OVA file along with a site-specific configuration. The virtual appliance can typically be imported and launched in as little as five minutes, and reduces security risks. As a part of the set-up, Cleerly’s implementation specialists remotely assist partners through the deployment, configuration and end-to-end testing of their first digital imaging and communications medicine (DICOM) uploads and optional PACS report delivery.

Once the patient’s risk is known, Cleerly’s technology enables characterization of the extent, severity, and type of atherosclerosis present, translating advanced imaging science into clinical insights. Cleerly’s proprietary and FDA-cleared AI machine learning algorithms generate a 3D model of the patient’s coronary arteries, identify their lumen and vessel walls, locate and quantify stenoses, as well as quantify and categorize plaque. This analysis provides vessel-by-vessel detail with precise phenotyping for each coronary artery and its branch. Comprehensive plaque assessment offers an at-a-glance view of characterized plaque volume by coronary region and delivers a clear and concise summary of identified stenosis by severity. Compared to outdated technologies that prioritize indirect markers, this method provides patients and providers a full understanding of an individual’s actual disease burden to determine optimal next treatment steps.

© Cleerly | https://cleerlyhealth.com

Personalizing cardiovascular care with a first-of-a-kind-staging system
Heart disease has only recently adopted a staging system similar to what is used across cancer and other chronic conditions for decades – a critical missed opportunity for prognosis and treatment. To support the use of preventive technology, Cleerly developed a four-stage system for measuring the disease burden of CAD based on atherosclerotic plaque. This system provides a first-of-its-kind methodology to describe the severity of heart disease risk.

However, measuring plaque is just the first step. Patients also need appropriate treatment plans that meet the needs of each stage of disease progression – not cholesterol or other indirect markers. To address this, Cleerly’s disease treatment algorithms integrate coronary atherosclerosis stages combined with the presence of additional risk factors – such as lipid disorders, diabetes, hypertension, obesity, and tobacco use – to help providers deliver effective personalized treatment recommendations.

Tracking disease to optimize therapeutic success
To improve patient outcomes, physicians must do more than put patients on a care plan. Clinical teams may also require the ability to track patients’ progress, demonstrating success over time. For example, if a patient’s disease progresses, providers can immediately change plans to administer new therapies. If their atherosclerosis stabilizes or regresses, they can be assured the right regimen is in place.

With Cleerly software, providers can compare clinically-indicated CCTA exams performed in the same patient at different times, such as before and following therapy initiation. This directly compares the volume and type of plaque as well as the presence and degree of any blockages, helping the provider determine the therapy’s effectiveness to make modifications if needed. Combining this staging system and recommended disease treatment algorithms, physicians can track as well as treat, providing a robust outlook for a patient’s future care journey.

Enabling heart attack prevention
Rapid, accurate, and comprehensive disease phenotyping is critical to the early identification and characterization of a patient’s heart attack risk. Clinical evidence indicates that CCTA technology, coupled with AI, is superior to traditional methods for identifying and defining arterial plaque. Through the adoption of this personalized care pathway, healthcare will no longer overlook patients who may suffer from a heart attack. With easy-to-use technologies that integrate into clinical workflows for increased efficiency and effectiveness, this type of platform empowers providers with insights to enact personalized, precision heart care for individuals living with or at risk of heart disease.