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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliero-Universitaria Sant'Andrea, Roma, RM, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Diagnostic accuracy of CCTA, CCTA plus FFR-CT, and CCTA plus spectral stress CT perfusion in the detection of hemodynamically relevant coronary stenosis

Time frame: 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

Time frame: 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.

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Palmisano, Medicine and Surgery

CONTACT

[email protected]

+39 3200985665

Davide Vignale, Medicine and Surgery

CONTACT

[email protected]

+39 3480521191

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Acronym: SURE-CT

Important dates

Study start: 2026
Primary completion: 2029
Study completion: 2029
First posted: Apr 22, 2026
Registry last updated: Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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