CaRi-Heart® for Coronary Artery Disease

(CARE-CCTA Trial)

Not yet recruiting at 17 trial locations

Overseen By HOUDA ABDALLAH, msn

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Corazon Medical PC

Disqualifiers: CABG, Structural heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a software tool called CaRi-Heart® can help doctors better understand and treat coronary artery disease. The tool uses AI to analyze images from routine heart scans to measure inflammation in the heart's arteries. This analysis might enable doctors to make more informed decisions about managing heart disease earlier. Individuals undergoing Coronary CT Angiography (CCTA) as part of their normal care, without a history of heart surgery, are well-suited for this trial. As an unphased trial, this study offers participants the chance to contribute to cutting-edge research that could enhance heart disease management for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the CaRi-Heart® analysis is safe for coronary artery disease patients?

Previous studies have used CaRi-Heart® analysis to predict heart disease risk by examining inflammation in the heart's arteries. This tool employs artificial intelligence (AI) to analyze images from standard heart scans. The analysis is non-invasive, as it does not involve surgery or entering the body. No reports indicate harm, as it only examines existing images. This makes it a safe option for those considering joining trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CaRi-Heart® Analysis because it offers a new way to assess coronary artery disease by focusing on coronary inflammation. Unlike standard treatments that mainly look at narrowing or blockages in arteries, this technique uses advanced software to analyze heart scans, providing unique insights into inflammation that might lead to better and more personalized treatment decisions. This innovation could help doctors identify patients at higher risk of heart problems earlier, potentially improving outcomes and tailoring care more effectively.

What evidence suggests that CaRi-Heart® analysis is effective for coronary artery disease?

Studies have shown that CaRi-Heart® analysis can predict a person's risk of a deadly heart event over the next eight years. This technology uses AI to detect inflammation in the heart's arteries, aiding doctors in identifying individuals at higher risk for heart problems. In this trial, participants will undergo standard CCTA with CaRi-Heart® software analysis to assess coronary inflammation and evaluate its impact on clinical decision-making. Research suggests that using CaRi-Heart® could reduce deaths from heart issues by 12% and decrease heart attacks by 11%. This approach may help doctors make more informed treatment decisions for heart disease, potentially improving patient health outcomes. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for patients who are already undergoing Coronary CT Angiography (CCTA) as part of their regular care. It's aimed at those who may be at risk of coronary artery disease, atherosclerosis, stroke, or heart inflammation.

Inclusion Criteria

Ability to provide written informed consent

Clinically indicated CCTA undertaken for evaluation of coronary artery disease

I am between 18 and 80 years old.

Exclusion Criteria

CCTA undertaken for structural heart disease evaluation (e.g. transcatheter aortic valve replacement (TAVR))

The CCTA is of poor quality or partly unanalysable due to artifacts, such as motion-artifacts, breathing-artifacts, stack-artifacts or blooming-artifacts

Inability to provide required health information

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

CCTA and CaRi-Heart® Analysis

Participants undergo standard Coronary CT Angiography (CCTA) with additional CaRi-Heart® software analysis to assess coronary inflammation and evaluate impact on clinical decision-making

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in clinical management decisions following CaRi-Heart® analysis

Up to 8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CaRi-Heart® Analysis

Trial Overview

The study tests CaRi-Heart®, an AI software that analyzes CCTA images to measure inflammation in the coronary arteries. The aim is to see if this tool influences doctors' decisions and improves early disease management.

How Is the Trial Designed?

Group I: CaRi-Heart® Analysis Group Experimental Treatment 1 Intervention

Participants receiving standard CCTA with CaRi-Heart® software analysis to assess coronary inflammation and evaluate impact on clinical decision-making.

Who Is Running the Clinical Trial?

Corazon Medical PC

Lead Sponsor

Citations

1.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/n/ukhta2831/s7/?report=reader

A cloud-based medical device for predicting cardiac risk in ...

The results of the included study indicate that CaRi-Heart Risk is predictive of a patient's absolute 8-year risk of a fatal cardiac event, when applied in a ...

2.

caristo.com

caristo.com/new-study-cari-heart-technology-highly-cost-effective-in-the-nhs/

CaRi-Heart® Technology Highly Cost-Effective in the NHS

The study shows that integrating the CaRi-Heart care pathway into routine care could reduce cardiac deaths by 12%, myocardial infarctions by 11% ...

3.

academic.oup.com

academic.oup.com/ehjqcco/article/11/4/434/7789847

Cost-effectiveness of a novel AI technology to quantify ...

A novel AI technology to quantify coronary inflammation and cardiovascular risk in patients undergoing routine coronary computed tomography angiography.

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06986733

Study of Management Alterations Resulting From CaRi- ...

This study is an observational study, in which clinicians will be presented with a patient's CCTA scan results and relevant clinical details ( ...

5.

nice.org.uk

nice.org.uk/guidance/hte4/documents/overview

Evidence overview: CaRi-Heart for predicting cardiac risk ...

The company claims that CaRi-Heart could help identify an individual's risk of cardiac mortality with greater discrimination than currently used risk factor-.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11299050/

A cloud-based medical device for predicting cardiac risk in ...

There is some evidence that CaRi-Heart Risk may be predictive of 8-year risk of cardiac death, for patients undergoing computed tomography coronary angiography ...

7.

caristo.com

caristo.com/cari-heart-technology/

CaRi-Heart® Technology

CaRi-Heart analysis generates an individualised risk score to aid diagnosis and management of coronary artery disease. Our AI-enabled CaRi-Heart Technology ...

8.

clinicaltrialsarena.com

clinicaltrialsarena.com/news/caristo-touts-study-showing-accuracy-of-its-cari-heart-technology/

Caristo touts study showing accuracy of its CaRi-Heart ...

The data, published in The Lancet, shows that among patients undergoing CCTA, over 80% without obstructive CAD [coronary artery disease] ...

9.

nice.org.uk

nice.org.uk/guidance/hte4/documents/d-a-r-comments-table-and-e-a-g-response

CaRi-Heart for predicting cardiac risk in suspected ...

Early value assessment: CaRi-Heart for predicting cardiac risk in suspected coronary artery disease ... outcomes data has been completed). We thank the ...