Spectral and Ultra High Resolution CT Systems for Non-Invasive Detection of Myocardial Ischemia: Stress CT Perfusion VS. FFR-CT

Обзор

Coronary artery disease (CAD) is the leading cause of mortality and morbidity worldwide. Coronary Computed Tomography angiography (CCTA) gained a pivotal clinical role for excellent sensitivity in rule-out CAD, but has limited specificity for a tendency to overestimate stenoses and for the lack of information about their hemodynamic impact. Fractional Flow Reserve derived from CT (FFR-CT) and stress CT perfusion (CTP) have been recently proposed to complement CCTA in the non-invasive assessment of myocardial ischemia, increasing the specificity and avoiding unnecessary catheterization. However, on energy-integrating (EID)-CT, FFR-CT has suboptimal performance, while CTP is affected by high radiation exposure. Both these approaches may benefit by the introduction of the new Photon Counting Detector (PCD)-CT technology, but data completely lacks. Aim of the study is to assess the performance of PCD-CT in the identification of significant CAD combining CCTA with FFR-CT and spectral CTP.

Первичные конечные точки

• Diagnostic accuracy of CCTA, CCTA plus FFR-CT, and CCTA plus spectral stress CT perfusion in the detection of hemodynamically relevant coronary stenosis [Срок оценки: 36 months]
• Evaluation of rest spectral CT perfusion for the assessment of haemodynamic significance of stenosis [Срок оценки: 36 months]
• Identification of geometric features from PCD-CT ultra high resolution CCTA associated to plaque-specific ischemia at invasive FFR. [Срок оценки: 36 months]

Критерии участия

Критерии включения

• Patient referred to our hospitals for elective CCTA for ruling out CAD
• CCTA evidence of moderate stenosis (50-69%) requiring functional assessment according to ESC guidelines

Критерии исключения

• hemodynamically unstable conditions,
• previous revascularization,
• myocardial infarction,
• obesity (BMI>40 kg/m2),
• renal insufficiency (GFR<30 mL/min),
• atrial fibrillation or other significant arrhythmias; and
• other overt cardiovascular diseases affecting CTP performance (e.g., heart failure, severe valvular regurgitation),
• pregnancy and breastfeeding,
• contraindications to iodinated contrast agents or regadenoson.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 2 центра

• Azienda Ospedaliero-Universitaria Sant'Andrea — Roma
• IRCCS Ospedale San Raffaele — Milan

Публикации

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Идентификаторы

NCT: NCT07544277 · GR-2024-12380180

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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