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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Aortic Valve Stenosis; Coronary Stenosis
• Intervention / Treatment: Diagnostic test: Aortic CTA, .23s; Diagnostic test: Aortic CTA, .28s

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
• Enrollment (Estimated): 124
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David C Rotzinger, MD, PhD; Phone Number: 021 314 44 75; Email: david.rotzinger@chuv.ch

Study Locations

• Switzerland
  • Lausanne, Switzerland, 1011
    • Recruiting
    • Lausanne University Hospital (CHUV)
    • Contact: David C. Rotzinger, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interpretable CTA rate per patient	Number of patients with diagnostic image quality for coronary artery disease	Up to 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interpretable CTA rate, per segment	Number of segments with diagnostic image quality for coronary artery disease	Up to 90 days
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
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
Quantitative image quality (contrast to noise ratio)	Comparison of contrast to noise ratio between both groups	Up to 90 days
Radiation dose per patient	Effective dose (mSv) comparison between both groups	Up to 90 days

Collaborators and Investigators

• Sponsor: David C. Rotzinger
• Investigators: Principal Investigator: David C. Rotzinger, MD, PhD, CHUV

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2024
• Primary Completion (Estimated): June 3, 2026
• Study Completion (Estimated): June 3, 2026

Study Registration Dates

• First Submitted: January 11, 2023
• First Submitted That Met QC Criteria: January 23, 2023
• First Posted (Actual): February 2, 2023

Study Record Updates

• Last Update Posted (Actual): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Diagnostic imaging; Image Processing, Computer-Assisted; Artifacts; Computed Tomography Angiography
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Coronary Disease; Cardiovascular Diseases; Aortic Valve Stenosis; Constriction, Pathologic; Coronary Stenosis; Anti-Infective Agents; Antiparasitic Agents; Ivermectin; Selamectin
• Other Study ID Numbers: BPR526

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No