NCT05709652

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Feb 2024Jun 2026

First Submitted

Initial submission to the registry

January 11, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
1.1 years until next milestone

Study Start

First participant enrolled

February 27, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2026

Last Updated

March 1, 2024

Status Verified

February 1, 2024

Enrollment Period

2.3 years

First QC Date

January 11, 2023

Last Update Submit

February 28, 2024

Conditions

Coronary StenosisAortic Valve StenosisCardiovascular Diseases

Keywords

Computed Tomography AngiographyArtifactsDiagnostic imagingImage Processing, Computer-Assisted

Outcome Measures

Primary Outcomes (1)

  • Interpretable CTA rate per patient

    Number of patients with diagnostic image quality for coronary artery disease

    Up to 90 days

Secondary Outcomes (5)

  • Interpretable CTA rate, per segment

    Up to 90 days

  • CTA performance to measure diameter stenosis, using invasive coronary angiography as gold standard

    Coronary angiography performed withing 30 days of CTA

  • Relationship between heart rate and non-diagnostic CTA

    Up to 90 days

  • Quantitative image quality (contrast to noise ratio)

    Up to 90 days

  • Radiation dose per patient

    Up to 90 days

Study Arms (2)

Experimental

EXPERIMENTAL

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

Diagnostic Test: Aortic CTA, .23s

Control

ACTIVE COMPARATOR

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

Diagnostic Test: Aortic CTA, .28s

Interventions

Aortic CTA, .23sDIAGNOSTIC_TEST

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

Also known as: GE Healthcare, Revolution Apex, cardiac and aortic CT angiography with 230 ms rotation time
Experimental
Aortic CTA, .28sDIAGNOSTIC_TEST

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

Also known as: GE Healthcare, Revolution Apex, cardiac and aortic CT angiography with 280 ms rotation time
Control

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjected to cardiac CT due to known or suspected aortic valve stenosis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lausanne University Hospital (CHUV)

Lausanne, 1011, Switzerland

RECRUITING

Related Publications (1)

  • 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.

    PMID: 37887871DERIVED

MeSH Terms

Conditions

Coronary StenosisAortic Valve StenosisCardiovascular Diseases

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesVascular DiseasesAortic Valve DiseaseHeart Valve DiseasesVentricular Outflow Obstruction

Study Officials

  • David C. Rotzinger, MD, PhD

    CHUV

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David C Rotzinger, MD, PhD

CONTACT

021 314 44 75david.rotzinger@chuv.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD, head of cardiovascular and thoracic radiology

Study Record Dates

First Submitted

January 11, 2023

First Posted

February 2, 2023

Study Start

February 27, 2024

Primary Completion (Estimated)

June 3, 2026

Study Completion (Estimated)

June 3, 2026

Last Updated

March 1, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)