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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cardiovascular Diseases. Basic parameters: 30 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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.
Primary outcome measures
- 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]
Secondary outcome measures (6)
- 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]
- 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]
- 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]
- 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]
- 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]
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06986733 · SMART-CCTA-1