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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Patients subjected to aortic CTA with a gantry revolution time of 0.23 sec |
|
| Control | Active Comparator | Patients subjected to aortic CTA with a gantry revolution time of 0.28 sec |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aortic CTA, .23s | Diagnostic Test | Aortic CTA performed with short (0.23 sec) gantry rotation time. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Interpretable CTA rate per patient | Number of patients with diagnostic image quality for coronary artery disease | Up to 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Interpretable CTA rate, per segment | Number of segments with diagnostic image quality for coronary artery disease | Up to 90 days |
| CTA performance to measure diameter stenosis, using invasive coronary angiography as gold standard |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David C Rotzinger, MD, PhD | Contact | 021 314 44 75 | david.rotzinger@chuv.ch |
| Name | Affiliation | Role |
|---|---|---|
| David C. Rotzinger, MD, PhD | CHUV | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lausanne University Hospital (CHUV) | Recruiting | Lausanne | 1011 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37887871 | Derived | 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. |
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| ID | Term |
|---|---|
| D023921 | Coronary Stenosis |
| D001024 | Aortic Valve Stenosis |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
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| Aortic CTA, .28s | Diagnostic Test | Aortic CTA performed with standard (.28 sec) gantry rotation time. |
|
|
CTA's diagnostic accuracy for coronary occlusive disease
| 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 | Up to 90 days |
| Quantitative image quality (contrast to noise ratio) | Comparison of contrast to noise ratio between both groups | Up to 90 days |
| Radiation dose per patient | Effective dose (mSv) comparison between both groups | Up to 90 days |
| D000082862 |
| Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D014694 | Ventricular Outflow Obstruction |