Aortic Valve Stenosis, Cardiovascular Diseases, Coronary Stenosis
Conditions
Keywords
Computed Tomography Angiography, Artifacts, Diagnostic imaging, Image Processing, Computer-Assisted
Brief 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. 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.
Interventions
DIAGNOSTIC_TESTAortic CTA, .23s
Aortic CTA performed with short (0.23 sec) gantry rotation time.
DIAGNOSTIC_TESTAortic CTA, .28s
Aortic CTA performed with standard (.28 sec) gantry rotation time.
Sponsors
David C. Rotzinger
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Interpretable CTA rate per patient | Up to 90 days | Number of patients with diagnostic image quality for coronary artery disease |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interpretable CTA rate, per segment | Up to 90 days | Number of segments with diagnostic image quality for coronary artery disease |
| CTA performance to measure diameter stenosis, using invasive coronary angiography as gold standard | Coronary angiography performed withing 30 days of CTA | CTA's diagnostic accuracy for coronary occlusive disease |
| Relationship between heart rate and non-diagnostic CTA | Up to 90 days | Correlation between of heart rate (in BPM) and the presence of any uninterpretable coronary segment on CTA |
| Quantitative image quality (contrast to noise ratio) | Up to 90 days | Comparison of contrast to noise ratio between both groups |
| Radiation dose per patient | Up to 90 days | Effective dose (mSv) comparison between both groups |
Countries
Switzerland
Contacts
Primary ContactDavid C Rotzinger, MD, PhD
Outcome results
None listed