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NCT05709652 | Recruiting | Coronary Stenosis


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

David C. Rotzinger

Information provided by (Responsible Party):

David C. Rotzinger

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.

Condition or disease

Coronary Stenosis

Aortic Valve Stenosis

Cardiovascular Diseases

Intervention/treatment

Aortic CTA, .23s

Aortic CTA, .28s

Phase

Not Applicable

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 Type : Interventional
Estimated Enrollment : 124 participants
Masking : Double
Primary Purpose : Diagnostic
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
Actual Study Start Date : February 27, 2024
Estimated Primary Completion Date : June 3, 2026
Estimated Study Completion Date : June 3, 2026
Arm Intervention/treatment

Experimental: Experimental

Patients subjected to aortic CTA with a gantry revolution time of 0.23 sec

Diagnostic Test: Aortic CTA, .23s

Active Comparator: Control

Patients subjected to aortic CTA with a gantry revolution time of 0.28 sec

Diagnostic Test: Aortic CTA, .28s

Ages Eligible for Study: 50 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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

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

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

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Locations


Recruiting

Switzerland,

Lausanne University Hospital (CHUV)

Lausanne, Switzerland, 1011

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