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)

Официальное название

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

Обзор

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.

Первичные конечные точки

• To assess the impact of CaRi-Heart® analysis on clinical decision making after CCTA in a US setting. [Срок оценки: Two weeks from initial review to review with CaRi-Heart results]

Вторичные конечные точки (6)

• To compare patient risk stratification with CaRi-Heart® analyses against standard clinical risk assessment tools (i.e., ASCVD-PCE). [Срок оценки: 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. [Срок оценки: 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). [Срок оценки: 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. [Срок оценки: 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.). [Срок оценки: 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) [Срок оценки: Two weeks from initial review to review with CaRi-Heart results]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06986733 · SMART-CCTA-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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