Coronary Artery DiseaseACDCNCT06499207
Advanced Coronary Plaque Morphology Assessment Using Photon-counting Detection and Invasive Coronary Imaging
A study testing Photon-counting detector computed tomography (PCD-CT) in people with Coronary Artery Disease and Coronary Disease, run by Medical University of Vienna.
Trial summary
This clinical trial aims to compare non-invasive photon-counting detector computed tomography (PCD-CT) with invasive intravascular imaging (IVI) for post-interventional follow-up in patients with coronary artery disease (CAD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Disease, PCI
- What is being tested?
- Photon-counting detector computed tomography (PCD-CT)
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2024to 15 Jul 2026
- Phase
- Interventional
- 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
Who may be able to join
- Signed written informed consent
- DES in proximal coronary vessel segments
Who cannot join
- Any conditions that may interfere with the safety or efficacy of CCTA
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This clinical trial aims to compare non-invasive photon-counting detector computed tomography (PCD-CT) with invasive intravascular imaging (IVI) for post-interventional follow-up in patients with coronary artery disease (CAD).
Participants will undergo post-interventional follow-up using both PCD-CT and coronary angiography with IVI. Researchers will test qualitative and quantitative PCD-CT results for non-inferiority to IVI regarding stent evaluation and detection of in-stent restenosis and plaque morphology.
- Conditions
- Coronary Artery Disease, Coronary Disease, PCI, Stent Restenosis
- Being tested
- Photon-counting detector computed tomography (PCD-CT)
- Medical subject headings
- Coronary Artery Disease, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photon-counting detector computed tomography (PCD-CT)Diagnostic test
Patients undergoing follow-up coronary angiography with IVI after percutaneous coronary intervention (PCI) as part of routine clinical practice will additionally receive coronary computed tomography angiography (CCTA) with PCD as part of this study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative comparison of PCD-CT and IVI in stent evaluation
Comparison of post-PCI minimal stent area, stent diameter, stent lumen visualization, coronary wall visualization
Measured: Within 1 year
Qualitative comparison of PCD-CT and IVI in stent evaluation
Two experienced radiologists/cardiologists will independently rate image noise and stent artefacts (1 = inadequate; 5 = excellent)
Measured: Within 1 year
Secondary outcomes (3)
Quantitative comparison of PCD-CT and IVI for the evaluation of in-stent restenosis
Severity of stenosis: Calculation of the percentage (%) of lumen diameter and lumen are stenosis with the appropriate CCTA and IVI analysis software
Measured: Within 1 year
Quantitative comparison of PCD-CT and IVI for the evaluation of plaque morphology
Plaque morphology: Characterization of plaque components using Hounsfield units (HU) with the appropriate CCTA and IVI analysis software
Measured: Within 1 year
Qualitative comparison of PCD-CT and IVI for the evaluation of in-stent restenosis and plaque morphology
Two experienced radiologists/cardiologists will independently rate the visualization of in-stent restenosis and plaque morphology using a five-point scale (1 = inadequate; 5 = excellent)
Measured: Within 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start20 Nov 2024 (estimated)
- Primary completion15 Jul 2025 (estimated)
- Study completion15 Jul 2026 (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 Medical University of ViennaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Steinacher, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499207
- Sponsor's protocol ID
- ACDC_2547
- Acronym
- ACDC
- Status last verified
- Nov 2024
- First submitted
- 11 Jun 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Coronary Plaque Morphology Assessment Using Photon-counting Detection and Invasive Coronary Imaging
- ClinicalTrials.gov ID
- NCT06499207
- Acronym / sponsor ID
- ACDC / ACDC_2547
- Conditions
- Coronary Artery Disease, Coronary Disease, PCI, Stent Restenosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 20 Nov 2024 (estimated)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 12 Jul 2024 (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.
This clinical trial aims to compare non-invasive photon-counting detector computed tomography (PCD-CT) with invasive intravascular imaging (IVI) for post-interventional follow-up in patients with coronary artery disease (CAD).
Participants will undergo post-interventional follow-up using both PCD-CT and coronary angiography with IVI. Researchers will test qualitative and quantitative PCD-CT results for non-inferiority to IVI regarding stent evaluation and detection of in-stent restenosis and plaque morphology.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Signed written informed consent
- DES in proximal coronary vessel segments
Key exclusion criteria (1 listed)
- Any conditions that may interfere with the safety or efficacy of CCTA
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 |
|---|---|---|
| Photon-counting detector computed tomography (PCD-CT)Patients undergoing follow-up coronary angiography with IVI after percutaneous coronary intervention (PCI) as part of routine clinical practice will additionally receive coronary computed tomography angiography (CCTA) with PCD as part of this study. | Diagnostic test | – |
Primary outcome
Quantitative comparison of PCD-CT and IVI in stent evaluation
Time frame: Within 1 year
Comparison of post-PCI minimal stent area, stent diameter, stent lumen visualization, coronary wall visualization
Qualitative comparison of PCD-CT and IVI in stent evaluation
Time frame: Within 1 year
Two experienced radiologists/cardiologists will independently rate image noise and stent artefacts (1 = inadequate; 5 = excellent)
3 secondary outcomes
Quantitative comparison of PCD-CT and IVI for the evaluation of in-stent restenosis
Time frame: Within 1 year
Quantitative comparison of PCD-CT and IVI for the evaluation of plaque morphology
Time frame: Within 1 year
Qualitative comparison of PCD-CT and IVI for the evaluation of in-stent restenosis and plaque morphology
Time frame: Within 1 year
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 20 Nov 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Photon-counting detector computed tomography (PCD-CT) in people with Coronary Artery Disease and Coronary Disease, run by Medical University of Vienna.
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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Eva Steinacher, MD (004314040046140, eva.steinacher@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative comparison of PCD-CT and IVI in stent evaluation (time frame: Within 1 year). The study lists 2 primary outcomes in all. 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 20 Nov 2024; AzTrials last refreshed its copy on 30 Oct 2026.