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)

NCT06986733 | Not Yet Recruiting

• 1 other identifier: SMART-CCTA-1
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

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

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

  Two weeks from initial review to review with CaRi-Heart results

Secondary Outcomes (6)

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

  Two weeks from initial review to review with CaRi-Heart results

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

  Two weeks from initial review to review with CaRi-Heart results

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

  Two weeks from initial review to review with CaRi-Heart results

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

  Two weeks from initial review to review with CaRi-Heart results

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

  Two weeks from initial review to review with CaRi-Heart results

Other Outcomes (1)

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

  Two weeks from initial review to review with CaRi-Heart results

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any participant who has had a clinically indicated analysable CCTA at the three hospital collaborators

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Caristo Diagnostics Limited: lead
• Arkansas Cardiology, P.A.: collaborator
• Baptist Health, Louisville: collaborator
• Northeast Georgia Hospital System: collaborator

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 23, 2025
• Study Start: June 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 23, 2025

Record last verified: 2025-05