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

Cardiovascular Diseases Clinical Trial

— FAST-CCT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05709652
• Other study ID #: BPR526
• Status: Recruiting
• Phase: N/A
• Start date: February 27, 2024
• Est. completion date: June 3, 2026

Study information

• Verified date: February 2024
• Source: University of Lausanne Hospitals
• Contact: David C Rotzinger, MD, PhD
• Phone: 021 314 44 75
• Email: david.rotzinger[@]chuv.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: June 3, 2026
• Est. primary completion date: June 3, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Cardiovascular Diseases
• Constriction, Pathologic
• Coronary Stenosis

Intervention

Diagnostic Test:
• Aortic CTA, .23s
Aortic CTA performed with short (0.23 sec) gantry rotation time.
• Aortic CTA, .28s
Aortic CTA performed with standard (.28 sec) gantry rotation time.

Locations

Country	Name	City	State
Switzerland	Lausanne University Hospital (CHUV)	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
David C. Rotzinger

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interpretable CTA rate per patient	Number of patients with diagnostic image quality for coronary artery disease	Up to 90 days
Secondary	Interpretable CTA rate, per segment	Number of segments with diagnostic image quality for coronary artery disease	Up to 90 days
Secondary	CTA performance to measure diameter stenosis, using invasive coronary angiography as gold standard	CTA's diagnostic accuracy for coronary occlusive disease	Coronary angiography performed withing 30 days of CTA
Secondary	Relationship between heart rate and non-diagnostic CTA	Correlation between of heart rate (in BPM) and the presence of any uninterpretable coronary segment on CTA	Up to 90 days
Secondary	Quantitative image quality (contrast to noise ratio)	Comparison of contrast to noise ratio between both groups	Up to 90 days
Secondary	Radiation dose per patient	Effective dose (mSv) comparison between both groups	Up to 90 days