Coronary Artery DiseaseAlpha RegistryNCT07016477
Prospective Registry of Patients Undergoing Cardiac CT With NAEOTOM Alpha PCD-CT Before TAVI Procedure
An observational study of Coronary Artery Disease and Aortic Valve Stenosis, run by Semmelweis University at 7 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Aortic Valve Stenosis, Tomography, X-Ray Computed
- What is being tested?
- Ultra-High Resolution Photon Counting Detector Coronary Computed Tomography Angiography
- How many people
- 1,000 participants
- Where
- 7 sitesin 5 countries
- Study dates
- 1 Jun 2024to 30 May 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients with aortic valve stenosis for whom TAVI is indicated and who present for pre-operative investigation.
Who may be able to join
- Clinically indicated TAVI
- Clinically indicated CT and invasive coronary angiography
- There are no contraindications to CT angiography.
- Understanding and signing the consent form
Who cannot join
- 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
Trial locations and contacts
7 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 5 countries
Germany3 sites, 3 recruiting
- Not yet recruiting
Albert-Ludwigs-Universität Freiburg
Freiburg im Breisgau, 79098
Fabian Bamberg, MD, 0049-761-270-38050, fabian.bamberg@uniklinik-freiburg.de
Christopher Schlett, MD
- Recruiting
University Medical Center Mainz
Mainz, 55116
Tilman Emrich, MD, +49613117 ext. 7358, Tilman.Emrich@unimedizin-mainz.de
Moritz Halfmann, MD
- Not yet recruiting
Universitätsklinikum Tübingen
Tübingen, 2669
Konstantin Nikolaou, MD, 07071 29-82087, konstantin.nikolaou@med.uni-tuebingen.de
Patrick Krumm, MD
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Akos Varga-Szemes, MD, PhD, +1843-876-7146, vargaasz@musc.edu
U. Joseph Schoepf, MD
Hungary1 site, 1 recruiting
- Recruiting
Semmelweis University
Budapest
Pál Maurovich-Horvat, MD, PhD, DSc, +36 1 459 1500 ext. 61661, maurovich-horvat.pal@semmelweis.hu
Bálint Szilveszter, MD, PhD
Netherlands1 site, 1 recruiting
- Not yet recruiting
Maastricht University
Maastricht, 6211
Joachim Wildberger, MD, +31(0)43 387 49 12, j.wildberger@mumc.nl
Casper Mihl, MD, PhD
Switzerland1 site, 1 recruiting
- Not yet recruiting
University Hospital of Zürich
Zurich, 8091
Hatem Alkadhi, MD, +41 44 255 36 62, hatem.alkadhi@usz.ch
Mihaly Károlyi, MD
About this study
Official title: Prospective Registry of Patients Undergoing Cardiac CT With NAEOTOM Alpha Photon Counting-detector CT Before Transcatheter Aortic Valve Implantation
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.
- Being tested
- Ultra-High Resolution Photon Counting Detector Coronary Computed Tomography Angiography
- Keywords
- photon-counting detector computed tomography
- Medical subject headings
- Coronary Artery Disease, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra-High Resolution Photon Counting Detector Coronary Computed Tomography AngiographyDiagnostic test
Also called Photon-Counting Detector CT (Naeotom Alpha, Siemens Healthineers)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Ultra-High Resolution Photon Counting Detector Coronary Computed Tomography Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 2 years
Secondary outcomes (24)
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.
Measured: through study completion, an average of 2 years
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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.
Measured: from inclusion up to a maximum follow-up period of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start1 Jun 2024
- Primary completion30 May 2029 (estimated)
- Study completion30 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Collaborators
- Siemens Corporation, Corporate Technology
- Responsible party
- Principal investigator, Prof. Maurovich-Horvat Pál, Semmelweis University
- Investigators
- Pál Maurovich-Horvat, MD, PhD, DSc, Principal investigator, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016477
- Sponsor's protocol ID
- BM/9095-1/2024
- Acronym
- Alpha Registry
- Status last verified
- Jun 2025
- First submitted
- 23 Feb 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Registry of Patients Undergoing Cardiac CT With NAEOTOM Alpha Photon Counting-detector CT Before Transcatheter Aortic Valve Implantation
- ClinicalTrials.gov ID
- NCT07016477
- Acronym / sponsor ID
- Alpha Registry / BM/9095-1/2024
- Keywords
- photon-counting detector computed tomography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Collaborators
- Siemens Corporation, Corporate Technology
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 30 May 2029 (estimated)
- Study completion
- 30 May 2030 (estimated)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aortic stenosis | – | Diagnostic Test: Ultra-High Resolution Photon Counting Detector Coronary Computed Tomography AngiographyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with aortic valve stenosis for whom TAVI is indicated and who present for pre-operative investigation.
Key inclusion criteria (4 listed)
- Clinically indicated TAVI
- Clinically indicated CT and invasive coronary angiography
- There are no contraindications to CT angiography.
- Understanding and signing the consent form
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultra-High Resolution Photon Counting Detector Coronary Computed Tomography AngiographyAlso: Photon-Counting Detector CT (Naeotom Alpha, Siemens Healthineers)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. | Diagnostic test | Aortic stenosis |
Primary outcome
Diagnostic Accuracy of Ultra-High Resolution Photon-Counting Detector Coronary Computed Tomography Angiography (UHR PCD-CT CCTA)
Time frame: 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
24 secondary outcomes
Image Noise Analysis Across Reconstruction Parameters
Time frame: through study completion, an average of 2 years
Correlation of Image Noise and Body Mass Index
Time frame: through study completion, an average of 2 years
Correlation of Image Noise and Heart Rate
Time frame: through study completion, an average of 2 years
Contrast-to-Noise Ratio (CNR) Analysis Across Reconstruction Parameters
Time frame: through study completion, an average of 2 years
Vessel Sharpness Analysis Across Reconstruction Parameters
Time frame: through study completion, an average of 2 years
Blooming Analysis Across Reconstruction Parameters
Time frame: through study completion, an average of 2 years
Subjective Image Quality Analysis
Time frame: through study completion, an average of 2 years
Correlation of Quantitative Coronary Artery Disease Assessment
Time frame: through study completion, an average of 2 years
Correlation of Quantitative In-Stent Restenosis Assessment
Time frame: through study completion, an average of 2 years
Correlation of Fractional Flow Reserve Measurement
Time frame: through study completion, an average of 2 years
Quantitative Assessment of Plaque Composition
Time frame: through study completion, an average of 2 years
Correlation of Plaque Composition
Time frame: through study completion, an average of 2 years
Quantitative Assessment of Extracellular Volume Fraction
Time frame: through study completion, an average of 2 years
Analysis of Structured Coronary Artery Disease Reporting in UHR PCD-CT
Time frame: through study completion, an average of 2 years
Correlation of Quantitative UHR PCD-CT CCTA Parameters with Ischemia Imaging Tests
Time frame: through study completion, an average of 2 years
Correlation of Quantitative UHR PCD-CT CCTA Parameters with Other Imaging Tests
Time frame: through study completion, an average of 2 years
Correlation Between PCAT Attenuation and CT-derieved or Clinical Parameters
Time frame: from inclusion up to a maximum follow-up period of 5 years
Correlation Between EAT Attenuation and CT-derieved or Clinical Parameters
Time frame: from inclusion up to a maximum follow-up period of 5 years
Lung Water Density Quantification
Time frame: through study completion, an average of 2 years
Assessment of Whole Body Extracellular Volume
Time frame: through study completion, an average of 2 years
Major Adverse Cardiac Events
Time frame: from inclusion up to a maximum follow-up period of 5 years
Extended Major Adverse Cardiovascular Events
Time frame: from inclusion up to a maximum follow-up period of 5 years
Prosthesis Function Evaluation
Time frame: from inclusion up to a maximum follow-up period of 5 years
Cost-effectiveness
Time frame: from inclusion up to a maximum follow-up period of 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pál Maurovich-Horvat, MD, PhD, DSc principal investigator
Semmelweis University
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Aortic Valve Stenosis, run by Semmelweis University at 7 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, United States, Hungary, Netherlands, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pál Maurovich-Horvat, MD, PhD, DSc (+3614591500 ext. 61628, maurovich-horvat.pal@semmelweis.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of Ultra-High Resolution Photon-Counting Detector Coronary Computed Tomography Angiography (UHR PCD-CT CCTA) (time frame: through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.