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NCT07544277Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 21 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
142 (estimated)
First submitted
15 Apr 2026
Start date
1 Sept 2026
Primary completion date
1 Apr 2029
Lead sponsor
IRCCS San Raffaele
NCT number
NCT07544277

What you commit to

  • Study type: Observational
  • Planned participants: 142
  • From 1 Sept 2026 to the primary completion date, 1 Apr 2029
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • previous revascularization,

Other illness

  • hemodynamically unstable conditions,
  • myocardial infarction,
  • atrial fibrillation or other significant arrhythmias; and
  • other overt cardiovascular diseases affecting CTP performance (e.g., heart failure, severe valvular regurgitation),

Lab values

  • renal insufficiency (GFR\<30 mL/min),

Other

  • obesity (BMI\>40 kg/m2),
  • pregnancy and breastfeeding,
  • contraindications to iodinated contrast agents or regadenoson.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
IRCCS Ospedale San Raffaele
Coordinator of this site? Confirm its status
MilanItalyUnknown status
Azienda Ospedaliero-Universitaria Sant'Andrea
Coordinator of this site? Confirm its status
RomaItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.