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Not yet recruiting NCT07544277

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

Conditions: FFR-CT CT Angiography CT Perfusion Coronary Arterial Disease (CAD)

Sponsor: IRCCS San Raffaele

trial.available_in: БГ
Overview
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.
Who can participate
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.
Locations 2
Italy (2)
IRCCS Ospedale San Raffaele
Milan
Azienda Ospedaliero-Universitaria Sant'Andrea
Roma , RM
Technical details
Status
Not yet recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.09.2026
Completion date
01.09.2029
Registry ID
NCT07544277
Source
clinicaltrials.gov
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