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

Sponsor

David C. Rotzinger (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05709652

Collaborator

(none)

124

Enrollment

Arms

24.1

Anticipated Duration (Months)

Study Details

Study Description

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	Intervention/Treatment	Phase
Coronary Stenosis Aortic Valve Stenosis Cardiovascular Diseases	Diagnostic Test: Aortic CTA, .23s Diagnostic Test: Aortic CTA, .28s	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

124 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Mar 3, 2025

Anticipated Study Completion Date :

Mar 3, 2025

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Experimental

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

Diagnostic Test: Aortic CTA, .23s

Aortic CTA performed with short (0.23 sec) gantry rotation time.

Other Names:

GE Healthcare, Revolution Apex, cardiac and aortic CT angiography with 230 ms rotation time

Active Comparator: Control

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

Diagnostic Test: Aortic CTA, .28s

Aortic CTA performed with standard (.28 sec) gantry rotation time.

Other Names:

GE Healthcare, Revolution Apex, cardiac and aortic CT angiography with 280 ms rotation time

Outcome Measures

Primary Outcome Measures

Interpretable CTA rate per patient [Up to 90 days]
Number of patients with diagnostic image quality for coronary artery disease

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts 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