Coronary Arterial Disease (CAD), CT Angiography, CT Perfusion, FFR-CT
Conditions
Keywords
FFR-CT, Coronary CT angiography, CT Perfusion, Coronary Arterial Disease (CAD)
Brief summary
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.
Interventions
None listed
Sponsors
IRCCS San Raffaele
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Italy
Contacts
CONTACTAnna Palmisano, Medicine and Surgery
CONTACTDavide Vignale, Medicine and Surgery
Outcome results
None listed