Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Siemens Corporation, Corporate Technology | INDUSTRY |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aortic stenosis | Patients with aortic valve disease for whom transcatheter aortic valve implantation is indicated and who present for pre-interventional evaluation will be enrolled after written consent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultra-High Resolution Photon Counting Detector Coronary Computed Tomography Angiography | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Accuracy of Ultra-High Resolution Photon-Counting Detector Coronary Computed Tomography Angiography (UHR PCD-CT CCTA) | 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 | through study completion, an average of 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Image Noise Analysis Across Reconstruction Parameters | 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. | through study completion, an average of 2 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Consecutive patients with aortic valve stenosis for whom TAVI is indicated and who present for pre-operative investigation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pál Maurovich-Horvat, MD, PhD, DSc | Contact | +3614591500 | 61628 | maurovich-horvat.pal@semmelweis.hu |
| Name | Affiliation | Role |
|---|---|---|
| Pál Maurovich-Horvat, MD, PhD, DSc | Semmelweis University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Recruiting | Charleston | South Carolina | 29425 | United States |
Not provided
Not provided
Not provided
Not provided
|
|
| Correlation of Image Noise and Body Mass Index |
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. |
| through study completion, an average of 2 years |
| Correlation of Image Noise and Heart Rate | 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. | through study completion, an average of 2 years |
| Contrast-to-Noise Ratio (CNR) Analysis Across Reconstruction Parameters | 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. | through study completion, an average of 2 years |
| Vessel Sharpness Analysis Across Reconstruction Parameters | 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. | through study completion, an average of 2 years |
| Blooming Analysis Across Reconstruction Parameters | Quantitative assessment of blooming (percentage) in CT images reconstructed with varying parameters, including reconstruction kernel type, quantum iterative reconstruction (QIR) levels, and slice thickness. | through study completion, an average of 2 years |
| Subjective Image Quality Analysis | 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. | through study completion, an average of 2 years |
| Correlation of Quantitative Coronary Artery Disease Assessment | Correlation and agreement of percent diameter stenosis (PDS) measured on UHR PCD-CT dataset and quantitative coronary angiography (QCA). | through study completion, an average of 2 years |
| Correlation of Quantitative In-Stent Restenosis Assessment | Correlation and agreement of quantitative in-stent restenosis (ISR) measured on UHR PCD-CT dataset and quantitative coronary angiography (QCA). | through study completion, an average of 2 years |
| Correlation of Fractional Flow Reserve Measurement | Correlation and agreement of CT-based fractional flow reserve (FFR-CT) measured on UHR PCD-CT dataset and invasive fractional flow reserve. | through study completion, an average of 2 years |
| Quantitative Assessment of Plaque Composition | 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. | through study completion, an average of 2 years |
| Correlation of Plaque Composition | 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. | through study completion, an average of 2 years |
| Quantitative Assessment of Extracellular Volume Fraction | Quantitative analysis of the extracellular volume (ECV) fraction measured on PCD-CT dataset. | through study completion, an average of 2 years |
| Analysis of Structured Coronary Artery Disease Reporting in UHR PCD-CT | Analysis of coronary artery disease classification according to the Coronary Artery Disease-Reporting and Data System (CAD-RADS 2.0). | through study completion, an average of 2 years |
| Correlation of Quantitative UHR PCD-CT CCTA Parameters with Ischemia Imaging Tests | 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). | through study completion, an average of 2 years |
| Correlation of Quantitative UHR PCD-CT CCTA Parameters with Other Imaging Tests | 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. | through study completion, an average of 2 years |
| Correlation Between PCAT Attenuation and CT-derieved or Clinical Parameters | 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. | from inclusion up to a maximum follow-up period of 5 years |
| Correlation Between EAT Attenuation and CT-derieved or Clinical Parameters | 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. | from inclusion up to a maximum follow-up period of 5 years |
| Lung Water Density Quantification | Measurement of lung water density by virtual non-contrast CT and iodine mapping CT, compared to non-contrast CT. | through study completion, an average of 2 years |
| Assessment of Whole Body Extracellular Volume | Assessment of whole body extracellular volume (ECV) in patients undergoing TAVI compared to healthy volunteer controls scanned in a separate study. | through study completion, an average of 2 years |
| Major Adverse Cardiac Events | Composite endpoint of major adverse cardiovascular event (MACE); defined as at least one of the following: cardiovascular death, nonfatal myocardial infarction, stroke. | from inclusion up to a maximum follow-up period of 5 years |
| Extended Major Adverse Cardiovascular Events | 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 | from inclusion up to a maximum follow-up period of 5 years |
| Prosthesis Function Evaluation | Subjective analysis of prosthesis function using UHR and spectral PCD-CT data to detect pathologies e.g. hypoattenuating leaflet thickening (HALT). | from inclusion up to a maximum follow-up period of 5 years |
| Cost-effectiveness | Costs of PCD-CT and complications compared with costs of ICA and complications. | from inclusion up to a maximum follow-up period of 5 years |
| Albert-Ludwigs-Universität Freiburg | Not yet recruiting | Freiburg im Breisgau | 79098 | Germany |
|
| University Medical Center Mainz | Recruiting | Mainz | 55116 | Germany |
|
| Universitätsklinikum Tübingen | Not yet recruiting | Tübingen | 2669 | Germany |
|
| Semmelweis University | Recruiting | Budapest | Hungary |
|
| Maastricht University | Not yet recruiting | Maastricht | 6211 | Netherlands |
|
| University Hospital of Zürich | Not yet recruiting | Zurich | 8091 | Switzerland |
|
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D014694 | Ventricular Outflow Obstruction |
Not provided
Not provided