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)

Caristo Diagnostics

Status: Not yet enrolling

Conditions: Cardiovascular Diseases

Study type: Observational

Funder types: Other; NETWORK; Industry

Identifiers

NCT06986733

SMART-CCTA-1

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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.