Clinical trial NCT05709652: Impact of Fast-rotation Coronary CT in Patients Undergoing Aortic Stenosis Workup
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Stenosis
Aortic Valve Stenosis
Cardiovascular Diseases
Keywords: Computed Tomography Angiography
Artifacts
Diagnostic imaging
Image Processing, Computer-Assisted
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 124
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Interpretable CTA rate per patient
timeFrame: Up to 90 days
Secondary outcomes:
measure: Interpretable CTA rate, per segment
timeFrame: Up to 90 days
measure: CTA performance to measure diameter stenosis, using invasive coronary angiography as gold standard
timeFrame: Coronary angiography performed withing 30 days of CTA
measure: Relationship between heart rate and non-diagnostic CTA
timeFrame: Up to 90 days
measure: Quantitative image quality (contrast to noise ratio)
timeFrame: Up to 90 days
measure: Radiation dose per patient
timeFrame: Up to 90 days
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Lausanne University Hospital (CHUV)
Study officials:
affiliation: CHUV
name: David C. Rotzinger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: