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Not Yet RecruitingNCT06986733

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)

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

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
300 (estimated)
Sponsor
Caristo Diagnostics Limited · Industry
Sex
All
Age
30 Years – 80 Years
Healthy volunteers
Not accepted

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

Timeline

Start date
2025-06-01
Primary completion
2025-12-31
Completion
2025-12-31
First posted
2025-05-23
Last updated
2025-05-23

Source: ClinicalTrials.gov record NCT06986733. Inclusion in this directory is not an endorsement.

Study of Management Alterations Resulting From CaRi-Heart® Technology in Patients Undergoing Coronary Computed Tomograph (NCT06986733) · Clinical Trials Directory