Impact of Fast-rotation Coronary CT in Patients Undergoing Aortic Stenosis Workup (FAST-CCT)

David C. Rotzinger

Status: Enrolling

Conditions: Aortic Valve Stenosis; Cardiovascular Diseases; Coronary Stenosis

Treatments: Diagnostic Test: Aortic CTA, .23s; Diagnostic Test: Aortic CTA, .28s

Study type: Interventional

Funder types: Other

Identifiers

NCT05709652

BPR526

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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124 participants in 2 patient groups

Experimental

Experimental group

Description:

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

Treatment:

Diagnostic Test: Aortic CTA, .23s

Control

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: Aortic CTA, .28s