Prospective Registry of Patients Undergoing Cardiac CT With NAEOTOM Alpha PCD-CT Before TAVI Procedure

Recruiting

• Conditions: Coronary Artery Disease; Aortic Valve Stenosis; Tomography, X-Ray Computed

• Registration Number: NCT07016477
• Lead Sponsor: Semmelweis University

Brief Summary

The clinical and demographic characteristics of patients undergoing transcatheter aortic valve implantation (TAVI) pose unique challenges for coronary computed tomography (CT) imaging, as this patient population is mainly composed of elderly, frail individuals with severe aortic stenosis, multiple comorbidities, high prevalence of heavily calcified coronary artery disease (CAD) and revascularized coronary arteries. Such vulnerable patients could benefit from a more precise assessment and characterization of their CAD with ultra-high resolution (UHR) photon-counting detector (PCD) CT that would potentially avoid the need for pre-implantation invasive coronary angiography (ICA). This international multicenter prospective registry study aims to investigate the feasibility and diagnostic accuracy of PCD-CT in the assessment of CAD in the high-risk population of patients undergoing TAVI, as compared to ICA.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-01
• Study First Submitted: 2025-02-23
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-04
• Last Update Submitted: 2025-06-04
• Study First Posted: 2025-06-11
• Last Update Posted: 2025-06-11
• Primary Completion: 2029-05-30
• Study Completion: 2030-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Clinically indicated TAVI
• Clinically indicated CT and invasive coronary angiography
• There are no contraindications to CT angiography.
• Understanding and signing the consent form

Exclusion Criteria

• Pregnancy or breastfeeding
• Chronic renal failure (eGFR <30 ml/m2)
• Active oncological treatment
• Any condition for which TAVI is contraindicated and therefore no prior radiological investigation of TAVI is indicated

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic Accuracy of Ultra-High Resolution Photon-Counting Detector Coronary Computed Tomography Angiography (UHR PCD-CT CCTA)	through study completion, an average of 2 years	Assessment of the diagnostic accuracy (sensitivity, specificity, PPV, NPV) of UHR PCD-CT coronary angiography as compared to invasive coronary angiography (ICA) within three months of PCD-CT

Secondary Outcome Measures

Name	Time	Method
Image Noise Analysis Across Reconstruction Parameters	through study completion, an average of 2 years	Quantitative assessment of image noise (measured in HU) in CT images reconstructed with varying parameters, including reconstruction kernel type, quantum iterative reconstruction (QIR) levels, and slice thickness.
Correlation of Image Noise and Body Mass Index	through study completion, an average of 2 years	Correlation of image noise (measured in HU) and body mass index (kg/m2) across different image reconstruction parameters, including kernel type, quantum iterative reconstruction (QIR) level, and slice thickness.
Blooming Analysis Across Reconstruction Parameters	through study completion, an average of 2 years	Quantitative assessment of blooming (percentage) in CT images reconstructed with varying parameters, including reconstruction kernel type, quantum iterative reconstruction (QIR) levels, and slice thickness.
Subjective Image Quality Analysis	through study completion, an average of 2 years	Overall image quality, image noise and vessel sharpness assessed on a 4-point Likert scale (1 = non-diagnostic, 4 = excellent) by 2 blinded readers/site. Comparison of image quality between reconstructions with varying parameters, including reconstruction kernel type, quantum iterative reconstruction (QIR) levels, and slice thickness.
Correlation of Quantitative Coronary Artery Disease Assessment	through study completion, an average of 2 years	Correlation and agreement of percent diameter stenosis (PDS) measured on UHR PCD-CT dataset and quantitative coronary angiography (QCA).
Correlation of Quantitative In-Stent Restenosis Assessment	through study completion, an average of 2 years	Correlation and agreement of quantitative in-stent restenosis (ISR) measured on UHR PCD-CT dataset and quantitative coronary angiography (QCA).
Correlation of Fractional Flow Reserve Measurement	through study completion, an average of 2 years	Correlation and agreement of CT-based fractional flow reserve (FFR-CT) measured on UHR PCD-CT dataset and invasive fractional flow reserve.
Quantitative Assessment of Plaque Composition	through study completion, an average of 2 years	Measure the volume of plaque components (in mm3) on UHR PCD-CT datasets across different image reconstruction parameters, including kernel type and quantum iterative reconstruction (QIR) level.
Correlation of Plaque Composition	through study completion, an average of 2 years	Correlation and agreement of plaque composition assessment from UHR PCD-CT dataset and intracoronary techniques such as optical coherence tomography (OCT) in patients who had both tests done.
Quantitative Assessment of Extracellular Volume Fraction	through study completion, an average of 2 years	Quantitative analysis of the extracellular volume (ECV) fraction measured on PCD-CT dataset.
Analysis of Structured Coronary Artery Disease Reporting in UHR PCD-CT	through study completion, an average of 2 years	Analysis of coronary artery disease classification according to the Coronary Artery Disease-Reporting and Data System (CAD-RADS 2.0).
Correlation of Quantitative UHR PCD-CT CCTA Parameters with Ischemia Imaging Tests	through study completion, an average of 2 years	Correlation of quantitative UHR PCD-CT CCTA parameters with the results of additional imaging ischemia tests in patients who had both PCD-CT CCTA and one of the following tests done: stress echocardiography, stress single photon emission computed tomography (SPECT), stress positron emission tomography (PET), and stress magnetic resonance imaging (MRI).
Correlation of Quantitative UHR PCD-CT CCTA Parameters with Other Imaging Tests	through study completion, an average of 2 years	Correlation of quantitative UHR PCD-CT CCTA parameters with the results of additional imaging tests in patients who had both PCD-CCTA and one of the following tests done: transthoracic echocardiography, transesophageal echocardiography, cardiac MRI.
Correlation Between PCAT Attenuation and CT-derieved or Clinical Parameters	from inclusion up to a maximum follow-up period of 5 years	To assess the correlation between pericoronary adipose tissue (PCAT) attenuation (measured in HU on UHR PCD-CT CCTA data) and (1) anatomical severity of CAD (percent diameter stenosis), (2) functional severity of disease (FFR-CT), (3) plaque composition and (4) clinical outcome.
Correlation Between EAT Attenuation and CT-derieved or Clinical Parameters	from inclusion up to a maximum follow-up period of 5 years	To assess the correlation between epicardial adipose tissue (EAT) attenuation (measured in HU on UHR PCD-CT CCTA data) and (1) anatomical severity of CAD (percent diameter stenosis), (2) functional severity of disease (FFR-CT), (3) plaque composition and (4) clinical outcome.
Lung Water Density Quantification	through study completion, an average of 2 years	Measurement of lung water density by virtual non-contrast CT and iodine mapping CT, compared to non-contrast CT.
Assessment of Whole Body Extracellular Volume	through study completion, an average of 2 years	Assessment of whole body extracellular volume (ECV) in patients undergoing TAVI compared to healthy volunteer controls scanned in a separate study.
Major Adverse Cardiac Events	from inclusion up to a maximum follow-up period of 5 years	Composite endpoint of major adverse cardiovascular event (MACE); defined as at least one of the following: cardiovascular death, nonfatal myocardial infarction, stroke.
Extended Major Adverse Cardiovascular Events	from inclusion up to a maximum follow-up period of 5 years	Composite endpoint of major adverse cardiovascular event (MACE); defined as at least one of the following: cardiovascular death, nonfatal myocardial infarction, stroke, unstable angina, or heart failure admission
Prosthesis Function Evaluation	from inclusion up to a maximum follow-up period of 5 years	Subjective analysis of prosthesis function using UHR and spectral PCD-CT data to detect pathologies e.g. hypoattenuating leaflet thickening (HALT).
Cost-effectiveness	from inclusion up to a maximum follow-up period of 5 years	Costs of PCD-CT and complications compared with costs of ICA and complications.
Correlation of Image Noise and Heart Rate	through study completion, an average of 2 years	Correlation of image noise (measured in HU) and heart rate (bpm) across different image reconstruction parameters, including kernel type, quantum iterative reconstruction (QIR) level, and slice thickness.
Contrast-to-Noise Ratio (CNR) Analysis Across Reconstruction Parameters	through study completion, an average of 2 years	Quantitative assessment of contrast-to-noise ratio (unitless) in CT images reconstructed with varying parameters, including reconstruction kernel type, quantum iterative reconstruction (QIR) levels, and slice thickness.
Vessel Sharpness Analysis Across Reconstruction Parameters	through study completion, an average of 2 years	Quantitative assessment of vessel sharpness (measured in 1/mm) in CT images reconstructed with varying parameters, including reconstruction kernel type, quantum iterative reconstruction (QIR) levels, and slice thickness.

Trial Locations

Locations (7)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Albert-Ludwigs-Universität Freiburg; 🇩🇪 Freiburg, Germany

University Medical Center Mainz; 🇩🇪 Mainz, Germany

Universitätsklinikum Tübingen; 🇩🇪 Tübingen, Germany

Semmelweis University; 🇭🇺 Budapest, Hungary

Maastricht University; 🇳🇱 Maastricht, Netherlands

University Hospital of Zürich; 🇨🇭 Zürich, Switzerland