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NCT Number: NCT06986733

Study of Management Alterations Resulting From CaRi-Heart® Technology in Patients Undergoing Coronary Computed Tomography Angiography (CCTA) for the Evaluation of Coronary Artery Disease: A United States Based Multi-Centre Study (SMART-CCTA-1)

This study is an assessment of the impact of CaRi-Heart® on the clinical management of patients across at least three centres in the USA. This study is an observational study, in which clinicians will be presented with a patient's CCTA scan results and relevant clinical details (such as blood test results and clinical risk factors) with the resulting clinical management recommendation recorded; they will then be presented with the results of the CaRi-Heart® analysis alongside any other relevant clinical details and any changes in clinical management recommendation will be recorded.

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Key information

Conditions

Cardiovascular Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinically indicated CCTA undertaken for evaluation of coronary artery disease.

Exclusion criteria

  • History of surgical revascularization (coronary artery bypass graft, CABG)
  • CCTA undertaken for structural heart disease evaluation (e.g. transcatheter aortic valve replacement (TAVR)
  • The CCTA is of poor quality or partly unanalyzable due to artifacts, such as motion-artifacts, breathing-artifacts, stack-artifacts or blooming-artifacts.

Treatment and study plan

Primary outcomes

  1. To assess the impact of CaRi-Heart® analysis on clinical decision making after CCTA in a US setting.

    Time frame: Two weeks from initial review to review with CaRi-Heart results

    The percentage of patients who received a change in recommended clinical management following review of their CaRi-Heart analysis.

Secondary outcomes

  1. To compare patient risk stratification with CaRi-Heart® analyses against standard clinical risk assessment tools (i.e., ASCVD-PCE).

    Time frame: Two weeks from initial review to review with CaRi-Heart results

    The percentage of patients reclassified into a higher (or lower) risk category using the CaRi-Heart® based AI-Risk classification, when compared to standard clinical risk assessment tools (i.e., ASCVD-PCE).

  2. Prevalence of high coronary inflammation (defined as FAI-Score in the 75th percentile) in the study population.

    Time frame: Two weeks from initial review to review with CaRi-Heart results

    The percentage patients who have FAI-Score above the 75th percentile.

  3. Prevalence of high coronary inflammation in participants with a 'normal' CCTA (i.e., CADRADS 0/1 or equivalent).

    Time frame: Two weeks from initial review to review with CaRi-Heart results

    The percentage patients with a CADRADs score of 0-1, who have FAI-Score above the 75th percentile.

  4. Sub-group analysis of prevalence of high coronary inflammation by clinical site and patient demographics.

    Time frame: Two weeks from initial review to review with CaRi-Heart results

    The percentage patients who have FAI-Score above the 75th percentile in each of the following sub-groups: geographical location, patient age, patient sex, patient ancestry.

  5. Correlation of FAI-Score with other available diagnostic test results (e.g., hsCRP, CACS etc.).

    Time frame: Two weeks from initial review to review with CaRi-Heart results

    The correlation coefficient for FAI-Score versus other available diagnostic test results (e.g., hsCRP, CACS etc.).

  6. Correlation of FAI-Score with quantitative plaque metrics (non-calcified plaque, calcified plaque, plaque burden)

    Time frame: Two weeks from initial review to review with CaRi-Heart results

    The correlation coefficient for FAI-Score versus the quantitative plaque metrics.

Other outcomes

  1. Prevalence of MACE in population with high coronary inflammation (FAI-Score ≥ 75th percentile) vs. those without (FAI-Score < 75th centile)

    Time frame: Two weeks from initial review to review with CaRi-Heart results

    A comparison of the number of major adverse cardiac events (MACE) in the population with high coronary inflammation (FAI-Score ≥ 75th percentile) vs. those without (FAI-Score < 75th centile)

Sponsors and collaborators

Lead sponsor

Caristo Diagnostics Limited

Industry

Collaborators

  • Arkansas Cardiology, P.A.
  • Baptist Health, Louisville
  • Northeast Georgia Hospital System

Registry information

Official study title

Study of Management Alterations Resulting From CaRi-Heart® Technology in Patients Undergoing Coronary Computed Tomography Angiography (CCTA) for the Evaluation of Coronary Artery Disease: A United States Based Multi-Centre Study

Acronym: SMART-CCTA-1

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 23, 2025
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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