Aortic Valve Stenosis, Coronary Artery Disease, Tomography, X-Ray Computed
Conditions
Keywords
photon-counting detector computed tomography
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.
Interventions
DIAGNOSTIC_TESTUltra-High Resolution Photon Counting Detector Coronary Computed Tomography Angiography
Clinically indicated Ultra-High Resolution Photon-Counting Detector Coronary Computed Tomography Angiography (UHR PCD-CT CCTA) for the pre-procedural evaluation of patients scheduled to undergo transcatheter aortic valve implantation.
Sponsors
Siemens Corporation, Corporate Technology
Semmelweis University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Germany, Hungary, Netherlands, Switzerland, United States
Contacts
Primary ContactPál Maurovich-Horvat, MD, PhD, DSc
Outcome results
None listed