Impact of Fast-rotation Coronary CT in Patients Undergoing Aortic Stenosis Workup

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Aortic Valve Stenosis, Coronary Stenosis, Cardiovascular Diseases

Intervention / Treatment
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* Diagnostic Test: Aortic CTA, .23s
* Diagnostic Test: Aortic CTA, .28s


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjected to cardiac CT due to known or suspected aortic valve stenosis Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Patients subjected to aortic CTA with a gantry revolution time of 0.23 sec | Diagnostic Test: Aortic CTA, .23s<br>* Aortic CTA performed with short (0.23 sec) gantry rotation time.<br>* Other names: GE Healthcare, Revolution Apex, cardiac and aortic CT angiography with 230 ms rotation time;|
| Active Comparator: Control<br>Patients subjected to aortic CTA with a gantry revolution time of 0.28 sec | Diagnostic Test: Aortic CTA, .28s<br>* Aortic CTA performed with standard (.28 sec) gantry rotation time.<br>* Other names: GE Healthcare, Revolution Apex, cardiac and aortic CT angiography with 280 ms rotation time;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interpretable CTA rate per patient | Number of patients with diagnostic image quality for coronary artery disease | Up to 90 days | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Computed Tomography Angiography, Artifacts, Diagnostic imaging, Image Processing, Computer-Assisted