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

NCT ID: NCT05709652

Last Updated: 2024-03-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-27
• Study Completion Date: 2026-06-03

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.

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.

Conditions

Coronary Stenosis; Aortic Valve Stenosis; Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Experimental

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

Group Type: EXPERIMENTAL

Aortic CTA, .23s

Intervention Type: DIAGNOSTIC_TEST

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

Control

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

Group Type: ACTIVE_COMPARATOR

Aortic CTA, .28s

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Aortic CTA, .23s

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

Intervention Type: DIAGNOSTIC_TEST

Aortic CTA, .28s

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

GE Healthcare, Revolution Apex, cardiac and aortic CT angiography with 230 ms rotation time; GE Healthcare, Revolution Apex, cardiac and aortic CT angiography with 280 ms rotation time

Eligibility 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

David C. Rotzinger

OTHER

Sponsor Role: lead

Responsible Party

David C. Rotzinger

MD, PhD, head of cardiovascular and thoracic radiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

David C. Rotzinger, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHUV

Locations

Lausanne University Hospital (CHUV)

Lausanne, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

David C Rotzinger, MD, PhD

Role: CONTACT

david.rotzinger@chuv.ch

021 314 44 75

Facility Contacts

David C. Rotzinger, MD, PhD

Role: primary

References

Fahrni G, Gullo G, Touray A, Fournier S, Jouannic AM, Lu H, Racine D, Muller O, Pozzessere C, Qanadli SD, Rotzinger DC. Investigating the Influence of High-Speed Gantry Rotation in Cardiac CT on Motion Artifacts in Aortic Stenosis Patients Not Premedicated with beta-Blockers: The FAST-CCT Randomized Trial Protocol. J Cardiovasc Dev Dis. 2023 Oct 12;10(10):424. doi: 10.3390/jcdd10100424.

Reference Type: DERIVED

PMID: 37887871 (View on PubMed)

Other Identifiers

BPR526

Identifier Type: -

Identifier Source: org_study_id