Low-dose Gated CT Validity for the Evaluation of Ascendant Aortic Aneurysm.

Not Applicable

Completed

• Conditions: Ascendant Aortic Aneurysm
• Interventions: Other: Modified Low-dose, EKG-gated CT without contrast for the evaluation of aortic aneurysm

• Registration Number: NCT03113539
• Lead Sponsor: Université de Sherbrooke

Brief Summary

We will demonstrate the validity of measurements with a low-dose, EKG-gated CT without contrast in the ascending aorta evaluation, compared with the current Angio-CT measurements.

Detailed Description

The actual protocol used in aorta evaluation consist of two CT-scans on the same study. The first scan that detects calcifications is using parameters with low-dose current, non EKG-gated and without contrast. The second scan uses iodine-contrast, EKG-gating and higher current dose to obtain higher image quality of diagnostic value.

The study will optimize the first scan parameters and compare the measures of the aorta diameters from the standard protocol.

By modifying the first scan parameters, we would demonstrate that the follow-up of an aortic aneurysm can safely be made with lower radiation exposure.

Study Timeline

• Study First Submitted: 2017-04-02
• Study First Submitted QC: 2017-04-08
• Study Start: 2017-04-12
• Study First Posted: 2017-04-13
• Primary Completion: 2019-04-30
• Study Completion: 2019-05-30
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-17
• Last Update Posted: 2019-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• 60 years old and more
• 85 bpm or less

Exclusion Criteria

• aortic material
• EKG gating not possible
• aorta pathology (thrombus, dissection)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects awaiting for an aortic evaluation	Modified Low-dose, EKG-gated CT without contrast for the evaluation of aortic aneurysm	Subjects already waiting for an aortic evaluation, either a first diagnostic scan or follow-up of a known aneurysm. Each subjects will have the two CT-scans on the same day.

Primary Outcome Measures

Name	Time	Method
Measures validity (aorta diameter in mm from scan images)	12 months	Comparing aorta diameters from the two modalities.

Secondary Outcome Measures

Name	Time	Method
Radiation (in msev from scanner report)	12 months	Comparing radiation exposure with the two modalities

Trial Locations

Locations (1)

Sherbrooke University Hospital; 🇨🇦 Sherbrooke, Quebec, Canada