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

NCT07544277 | Not Yet Recruiting

• 1 other identifier: GR-2024-12380180
• Study Type: observational
• Target: 142
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

FFR-CT; Coronary CT angiography; CT Perfusion; Coronary Arterial Disease (CAD)

Outcome Measures

Primary Outcomes (3)

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

  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.

  36 months

• Evaluation of rest spectral CT perfusion for the assessment of haemodynamic significance of stenosis

  Coronary stenosis severity at CCTA; myocardial iodine uptake at baseline, rest, and stress CTP; diagnostic performance of iodine uptake values against invasive FFR.

  36 months

• Identification of geometric features from PCD-CT ultra high resolution CCTA associated to plaque-specific ischemia at invasive FFR.

  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.

  36 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

142 patients (age\>18 years old) referred to our hospitals for elective CCTA for ruling out CAD and CCTA evidence of moderate stenosis (50-69%) requiring functional assessment according to ESC guidelines (1) because is known that not all anatomical stenosis in the range of moderate (50-69%) are haemodynamically significant (2) or induce myocardial ischaemia (3).

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (2)

Azienda Ospedaliero-Universitaria Sant'Andrea

Roma, RM, 00189, Italy

Location

IRCCS Ospedale San Raffaele

Milan, Italy

Location

Related Publications (19)

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Central Study Contacts

Anna Palmisano, Medicine and Surgery

CONTACT

+39 3200985665; palmisano.anna@hsr.it

Davide Vignale, Medicine and Surgery

CONTACT

+39 3480521191; vignale.davide@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 22, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

IT (2)