Coronary StenosisFAST-CCTNCT05709652
Impact of Fast-rotation Coronary CT in Patients Undergoing Aortic Stenosis Workup
A study testing Aortic CTA, .23s and Aortic CTA, .28s in people with Coronary Stenosis and Aortic Valve Stenosis, run by David C. Rotzinger at 1 site in Switzerland.
Trial summary
This study aims to evaluate the clinical value of a novel CT gantry supporting a .23 second rotation time and systematically compare it with 0.23 second rotation time, in patients with clinically indicated aortic CTA in the workup of aortic stenosis. Patients will be randomly assigned .23 or .28 sec rotation time CTA. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Coronary Stenosis, Aortic Valve Stenosis, Cardiovascular Diseases
- What is being tested?
- Aortic CTA, .23s and Aortic CTA, .28s
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteSwitzerland
- Study dates
- 27 Feb 2024to 3 Jun 2026
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjected to cardiac CT due to known or suspected aortic valve stenosis
Who cannot join
- Patients unable to hold their breath, deaf or visually impaired
- Estimated glomerular filtration rate (eGFR) of <30 mL/min
- Hemodynamic instability or cardiogenic shock, Acute pulmonary edema, Exacerbated chronic obstructive pulmonary disease, Pregnant and breast-feeding women
- Patients with prior coronary artery bypass grafting (CABG)
- Patient incapable of discernment
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Lausanne University Hospital (CHUV)
Lausanne, 1011
David C. Rotzinger, MD, PhD
About this study
Official title: Impact of Fast Gantry Rotation Cardiac CT Angiography on Coronary Motion Artifacts in the Absence of β-Blocker Premedication in Patients Undergoing Aortic Stenosis Workup: a Single-centre Randomized Controlled Trial
This study aims to evaluate the clinical value of a novel CT gantry supporting a .23 second rotation time and systematically compare it with 0.23 second rotation time, in patients with clinically indicated aortic CTA in the workup of aortic stenosis. Patients will be randomly assigned .23 or .28 sec rotation time CTA. Coronary artery interpretability rates will be determined in both groups.
Read the detailed description
Coronary artery analysis is an essential component of cardiac CT, but is often challenging without beta-blocker use. CT's technological advances are continuously evolving, paving the way for safer and more accurate diagnoses. Part of these innovations is the development of faster rotation speeds (0.23 sec/rotation), which is expected to allow for heart rate-independent CCTA.
Patients subjected to aortic stenosis workup routinely undergo invasive coronary angiography (ICA) in the catheterization laboratory, voiding the need to control the heart rate at the time of cardiac CT because aortic valve measurements can be performed even at higher heart rate. Still, cardiac CT in this context is performed with ECG-gating, and attempting to evaluate coronary arteries is possible without interfering with clinical decisions. Also, the existing literature advocates the use of gantry rotation speeds of at least 0.5 sec/rotation; consequently, the use of 0.28 versus 0.23 sec/rotation for this study will comply with current guidelines and will have no detrimental impact on patient management. This study aims to evaluate coronary artery interpretability in patients subjected to cardiac CT for the anatomical assessment of aortic valve stenosis prior to endovascular (transcatheter aortic valve implantation [TAVI]) or surgical therapy.
Patients will be enrolled after providing written, informed consent, and will be randomly assigned either to the test (0.23 sec rotation time) or control group (0.28 sec rotation).
The participants concerned are not subjected to any additional invasive or stressful procedure compared with those undergoing aortic stenosis workup in clinical routine.
- Being tested
- Aortic CTA, .23s, Aortic CTA, .28s
- Keywords
- Computed Tomography Angiography, Artifacts, Diagnostic imaging, Image Processing, Computer-Assisted
- Medical subject headings
- Coronary Stenosis, Aortic Valve Stenosis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aortic CTA, .23sDiagnostic test
Also called GE Healthcare, Revolution Apex, cardiac and aortic CT angiography with 230 ms rotation time
Aortic CTA performed with short (0.23 sec) gantry rotation time.
Aortic CTA, .28sDiagnostic test
Also called GE Healthcare, Revolution Apex, cardiac and aortic CT angiography with 280 ms rotation time
Aortic CTA performed with standard (.28 sec) gantry rotation time.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Patients subjected to aortic CTA with a gantry revolution time of 0.23 sec Receives: Diagnostic Test: Aortic CTA, .23s |
| Control | Active comparator | Patients subjected to aortic CTA with a gantry revolution time of 0.28 sec Receives: Diagnostic Test: Aortic CTA, .28s |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interpretable CTA rate per patient
Number of patients with diagnostic image quality for coronary artery disease
Measured: Up to 90 days
Secondary outcomes (5)
Interpretable CTA rate, per segment
Number of segments with diagnostic image quality for coronary artery disease
Measured: Up to 90 days
CTA performance to measure diameter stenosis, using invasive coronary angiography as gold standard
CTA's diagnostic accuracy for coronary occlusive disease
Measured: Coronary angiography performed withing 30 days of CTA
Relationship between heart rate and non-diagnostic CTA
Correlation between of heart rate (in BPM) and the presence of any uninterpretable coronary segment on CTA
Measured: Up to 90 days
Quantitative image quality (contrast to noise ratio)
Comparison of contrast to noise ratio between both groups
Measured: Up to 90 days
Radiation dose per patient
Effective dose (mSv) comparison between both groups
Measured: Up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start27 Feb 2024
- Primary completion3 Jun 2026 (estimated)
- Study completion3 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary StenosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David C. Rotzinger
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David C. Rotzinger, University of Lausanne Hospitals
- Investigators
- David C. Rotzinger, MD, PhD, Principal investigator, CHUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709652
- Sponsor's protocol ID
- BPR526
- Acronym
- FAST-CCT
- Status last verified
- Feb 2024
- First submitted
- 11 Jan 2023
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fahrni G, Gullo G, Touray A, Fournier S, Jouannic AM, Lu H, Racine D, Muller O, Pozzessere C, Qanadli SD, Rotzinger DC. Investigating the Influence of High-Speed Gantry Rotation in Cardiac CT on Motion Artifacts in Aortic Stenosis Patients Not Premedicated with beta-Blockers: The FAST-CCT Randomized Trial Protocol. J Cardiovasc Dev Dis. 2023 Oct 12;10(10):424. doi: 10.3390/jcdd10100424.
PubMed 37887871
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Fast Gantry Rotation Cardiac CT Angiography on Coronary Motion Artifacts in the Absence of β-Blocker Premedication in Patients Undergoing Aortic Stenosis Workup: a Single-centre Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05709652
- Acronym / sponsor ID
- FAST-CCT / BPR526
- Keywords
- Computed Tomography Angiography, Artifacts, Diagnostic imaging, Image Processing, Computer-Assisted
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- David C. RotzingerUniversity, hospital or other
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 3 Jun 2026 (estimated)
- Study completion
- 3 Jun 2026 (estimated)
- First posted
- 2 Feb 2023 (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 study aims to evaluate the clinical value of a novel CT gantry supporting a .23 second rotation time and systematically compare it with 0.23 second rotation time, in patients with clinically indicated aortic CTA in the workup of aortic stenosis. Patients will be randomly assigned .23 or .28 sec rotation time CTA. Coronary artery interpretability rates will be determined in both groups.
Detailed description
Coronary artery analysis is an essential component of cardiac CT, but is often challenging without beta-blocker use. CT's technological advances are continuously evolving, paving the way for safer and more accurate diagnoses. Part of these innovations is the development of faster rotation speeds (0.23 sec/rotation), which is expected to allow for heart rate-independent CCTA.
Patients subjected to aortic stenosis workup routinely undergo invasive coronary angiography (ICA) in the catheterization laboratory, voiding the need to control the heart rate at the time of cardiac CT because aortic valve measurements can be performed even at higher heart rate. Still, cardiac CT in this context is performed with ECG-gating, and attempting to evaluate coronary arteries is possible without interfering with clinical decisions. Also, the existing literature advocates the use of gantry rotation speeds of at least 0.5 sec/rotation; consequently, the use of 0.28 versus 0.23 sec/rotation for this study will comply with current guidelines and will have no detrimental impact on patient management. This study aims to evaluate coronary artery interpretability in patients subjected to cardiac CT for the anatomical assessment of aortic valve stenosis prior to endovascular (transcatheter aortic valve implantation [TAVI]) or surgical therapy.
Patients will be enrolled after providing written, informed consent, and will be randomly assigned either to the test (0.23 sec rotation time) or control group (0.28 sec rotation).
The participants concerned are not subjected to any additional invasive or stressful procedure compared with those undergoing aortic stenosis workup in clinical routine.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Diagnostic Test: Aortic CTA, .23sPatients subjected to aortic CTA with a gantry revolution time of 0.23 sec |
| Control | Active comparator | Diagnostic Test: Aortic CTA, .28sPatients subjected to aortic CTA with a gantry revolution time of 0.28 sec |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjected to cardiac CT due to known or suspected aortic valve stenosis
Key exclusion criteria (5 listed)
- Patients unable to hold their breath, deaf or visually impaired
- Estimated glomerular filtration rate (eGFR) of <30 mL/min
- Hemodynamic instability or cardiogenic shock, Acute pulmonary edema, Exacerbated chronic obstructive pulmonary disease, Pregnant and breast-feeding women
- Patients with prior coronary artery bypass grafting (CABG)
- Patient incapable of discernment
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 |
|---|---|---|
| Aortic CTA, .23sAlso: GE Healthcare, Revolution Apex, cardiac and aortic CT angiography with 230 ms rotation timeAortic CTA performed with short (0.23 sec) gantry rotation time. | Diagnostic test | Experimental |
| Aortic CTA, .28sAlso: GE Healthcare, Revolution Apex, cardiac and aortic CT angiography with 280 ms rotation timeAortic CTA performed with standard (.28 sec) gantry rotation time. | Diagnostic test | Control |
Primary outcome
Interpretable CTA rate per patient
Time frame: Up to 90 days
Number of patients with diagnostic image quality for coronary artery disease
5 secondary outcomes
Interpretable CTA rate, per segment
Time frame: Up to 90 days
CTA performance to measure diameter stenosis, using invasive coronary angiography as gold standard
Time frame: Coronary angiography performed withing 30 days of CTA
Relationship between heart rate and non-diagnostic CTA
Time frame: Up to 90 days
Quantitative image quality (contrast to noise ratio)
Time frame: Up to 90 days
Radiation dose per patient
Time frame: Up to 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Derived from this study: PubMed 37887871Fahrni G, Gullo G, Touray A, Fournier S, Jouannic AM, Lu H, Racine D, Muller O, Pozzessere C, Qanadli SD, Rotzinger DC. Investigating the Influence of High-Speed Gantry Rotation in Cardiac CT on Motion Artifacts in Aortic Stenosis Patients Not Premedicated with beta-Blockers: The FAST-CCT Randomized Trial Protocol. J Cardiovasc Dev Dis. 2023 Oct 12;10(10):424. doi: 10.3390/jcdd10100424.
- Individual participant dataSharing planned: No
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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.
David C. Rotzinger, MD, PhD principal investigator
CHUV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aortic CTA, .23s and Aortic CTA, .28s in people with Coronary Stenosis and Aortic Valve Stenosis, run by David C. Rotzinger at 1 site in Switzerland.
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 1 inclusion and 5 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 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David C Rotzinger, MD, PhD (021 314 44 75, david.rotzinger@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interpretable CTA rate per patient (time frame: Up to 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05709652, which also lists 1 linked publication.
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 1 Mar 2024.