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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Primary outcome measure(s)
Diagnostic accuracy of CCTA, CCTA plus FFR-CT, and CCTA plus spectral stress CT perfusion in the detection of hemodynamically relevant coronary stenosis — 36 months CCTA-derived stenosis and plaque characterization; CT-FFR values from commercial and in-house solutions; CTP-derived iodine uptake measurement; invasive FFR as reference standard. Comparison of off-site versus on-site CT-FFR solutions determined against invasive FFR.
Evaluation of rest spectral CT perfusion for the assessment of haemodynamic significance of stenosis — 36 months Coronary stenosis severity at CCTA; myocardial iodine uptake at baseline, rest, and stress CTP; diagnostic performance of iodine uptake values against invasive FFR.
Identification of geometric features from PCD-CT ultra high resolution CCTA associated to plaque-specific ischemia at invasive FFR. — 36 months Blinded analysis of baseline CCTA for qualitative and quantitative plaque characteristics, with correlation to invasive FFR. Inter-rater agreement assessment between two expert readers. Deep learning-based radiomic feature extraction from plaques and vessel walls. Development of a data-driven feature selection pipeline to predict hemodynamically significant stenosis from CCTA data, using invasive FFR as reference.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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