Coronary Artery DiseaseNCT05245149
Image Quality and Radiation Dose Associated With Cardiac Scans in Modern CT Scanners
An observational study of Coronary Artery Disease, run by University Hospital Augsburg.
Trial summary
The main objective of this study is to evaluate the dose efficiency of coronary CT angiography (CTA) using a photon counting detector CT (PCD-CT) with the dose efficiency of coronary CT angiography of prior CT generations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Cardiac CTA on a photon-counting detector CT (PCD-CT) and Cardiac CTA on a regular CT with Energy-Integrating Detector (EID-CT)
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2022to 30 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients who are at least 18 years of age with a clincially indication for a coronary CTA scan. Indication ('justified indication' according to German/European radiation protection law) must be confirmed by a board-certified radiologist.
Who may be able to join
- indication for coronary CTA confirmed by board-certified radiologist ('justified indication' according to German/European radiation protection law) AND
- patient (is able to give informed consent and) has given informed consent.
Who cannot join
- contraindications to (iodine based) iv contrast material: known allergy to iodine-based iv contrast, acute or high-grade chronic kidney insufficiency with an estimated glomerular filtration rate < 30 ml/min/1.73 m², latent or manifest hyperthyroidism
- known or suspected pregnancy
- lactating mothers
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prospective Observational Study of Image Quality and Radiation Dose Associated With Cardiac Scans in Modern CT Scanners
The main objective of this study is to evaluate the dose efficiency of coronary CT angiography (CTA) using a photon counting detector CT (PCD-CT) with the dose efficiency of coronary CT angiography of prior CT generations. 100 patients with a clinical indication for coronary CT angiography will be prospectively enrolled and undergo coronary CTA on a PCD-CT. For comparison, a matched retrospective cohort of 100 patients will be created who had undergone on a prior scanner generation (retrospective cohort).
- Conditions
- Coronary Artery Disease
- Being tested
- Cardiac CTA on a photon-counting detector CT (PCD-CT), Cardiac CTA on a regular CT with Energy-Integrating Detector (EID-CT)
- Keywords
- Spectral CT, Multi-Energy CT, Photon Counting Detector CT, PCD-CT
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac CTA on a photon-counting detector CT (PCD-CT)Diagnostic test
Cardiac CTA will be performed on a dual-source photon-counting CT
Cardiac CTA on a regular CT with Energy-Integrating Detector (EID-CT)Diagnostic test
Cardiac CTA was performed on a dual-source CT with regular energy-integrating detector (EID-CT)
| Study group | Role | What they receive |
|---|---|---|
| Prospective Cohort | Patients with a clinical indication for coronary CT angiography will undergo this scan on a photon counting detector CT (PCD-CT). Receives: Diagnostic Test: Cardiac CTA on a photon-counting detector CT (PCD-CT) | |
| Retrospective Cohort | For comparison, a matched retrospective cohort will be created of patients who had undergone coronary CT angiography on prior CT scanner generations (with energy-integrating detector CT, EID-CT) Receives: Diagnostic Test: Cardiac CTA on a regular CT with Energy-Integrating Detector (EID-CT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraluminal Enhancement of Coronary Arteries
measured on thin-slice reconstructions, in Hounsfield units
Measured: 1 year
Image Noise
measured on thin-slice reconstructions, in Hounsfield units
Measured: 1 year
Overall subjective image quality
as assessed by board-certified and speciality-trained radiologists on a 5-point Likert scale
Measured: 1 year
Dose-Length Product (DLP)
Integrative descriptor for the x-ray dose applied during acquisition; can be read out from the scan protocol.
Measured: 1 year
Secondary outcomes (1)
Diagnostic Accuracy of Coronary Artery Stenosis Assessment in Comparison with invasive catheter angiography
Comparison in the subgroups of patients who als undergo invasive catheter angiography
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start20 Feb 2022 (estimated)
- Primary completion30 Aug 2023 (estimated)
- Study completion30 Aug 2024 (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.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Augsburg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florian Schwarz, MD, Principal investigator, University Hospital Augsburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245149
- Sponsor's protocol ID
- 21-0383
- Status last verified
- Jul 2021
- First submitted
- 15 Jul 2021
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share individual participant data upon request (pending final approval by the data protection officer of the university hospital).
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study of Image Quality and Radiation Dose Associated With Cardiac Scans in Modern CT Scanners
- ClinicalTrials.gov ID
- NCT05245149
- Acronym / sponsor ID
- 21-0383
- Conditions
- Coronary Artery Disease
- Keywords
- Spectral CT, Multi-Energy CT, Photon Counting Detector CT, PCD-CT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital AugsburgUniversity, hospital or other
- Study start
- 20 Feb 2022 (estimated)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 17 Feb 2022 (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 main objective of this study is to evaluate the dose efficiency of coronary CT angiography (CTA) using a photon counting detector CT (PCD-CT) with the dose efficiency of coronary CT angiography of prior CT generations. 100 patients with a clinical indication for coronary CT angiography will be prospectively enrolled and undergo coronary CTA on a PCD-CT. For comparison, a matched retrospective cohort of 100 patients will be created who had undergone on a prior scanner generation (retrospective cohort).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective Cohort | – | Diagnostic Test: Cardiac CTA on a photon-counting detector CT (PCD-CT)Patients with a clinical indication for coronary CT angiography will undergo this scan on a photon counting detector CT (PCD-CT). |
| Retrospective Cohort | – | Diagnostic Test: Cardiac CTA on a regular CT with Energy-Integrating Detector (EID-CT)For comparison, a matched retrospective cohort will be created of patients who had undergone coronary CT angiography on prior CT scanner generations (with energy-integrating detector CT, EID-CT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are at least 18 years of age with a clincially indication for a coronary CTA scan. Indication ('justified indication' according to German/European radiation protection law) must be confirmed by a board-certified radiologist.
Key inclusion criteria (2 listed)
- indication for coronary CTA confirmed by board-certified radiologist ('justified indication' according to German/European radiation protection law) AND
- patient (is able to give informed consent and) has given informed consent.
Key exclusion criteria (3 listed)
- contraindications to (iodine based) iv contrast material: known allergy to iodine-based iv contrast, acute or high-grade chronic kidney insufficiency with an estimated glomerular filtration rate < 30 ml/min/1.73 m², latent or manifest hyperthyroidism
- known or suspected pregnancy
- lactating mothers
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 |
|---|---|---|
| Cardiac CTA on a photon-counting detector CT (PCD-CT)Cardiac CTA will be performed on a dual-source photon-counting CT | Diagnostic test | Prospective Cohort |
| Cardiac CTA on a regular CT with Energy-Integrating Detector (EID-CT)Cardiac CTA was performed on a dual-source CT with regular energy-integrating detector (EID-CT) | Diagnostic test | Retrospective Cohort |
Primary outcome
Intraluminal Enhancement of Coronary Arteries
Time frame: 1 year
measured on thin-slice reconstructions, in Hounsfield units
Image Noise
Time frame: 1 year
measured on thin-slice reconstructions, in Hounsfield units
Overall subjective image quality
Time frame: 1 year
as assessed by board-certified and speciality-trained radiologists on a 5-point Likert scale
Dose-Length Product (DLP)
Time frame: 1 year
Integrative descriptor for the x-ray dose applied during acquisition; can be read out from the scan protocol.
1 secondary outcome
Diagnostic Accuracy of Coronary Artery Stenosis Assessment in Comparison with invasive catheter angiography
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- Individual participant dataSharing planned: Yes. We plan to share individual participant data upon request (pending final approval by the data protection officer of the university hospital).
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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. This study is not recruiting at the moment.
Florian Schwarz, MD principal investigator
University Hospital Augsburg
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by University Hospital Augsburg.
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 3 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: status not confirmed, as of the sponsor's last update on 17 Feb 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Florian Schwarz, MD (+49821400 ext. 2441, radiologie-studien@uk-augsburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraluminal Enhancement of Coronary Arteries (time frame: 1 year). The study lists 4 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 17 Feb 2022.