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

Low-dose, EKG-gated CT Validity for the Evaluation of Ascendant Aortic Aneurysm.

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.

Study Overview

• Status: Completed
• Conditions: Ascendant Aortic Aneurysm
• Intervention / Treatment: Other: Modified Low-dose, EKG-gated CT without contrast for the evaluation of aortic aneurysm

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 Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H5N4
      • Sherbrooke University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 60 years old and more
• 85 bpm or less

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subjects awaiting for an aortic evaluation; 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.	Other: Modified Low-dose, EKG-gated CT without contrast for the evaluation of aortic aneurysm; On the same day, the subject will do : Modified low-dose, EKG-gated CT without contrast; Usual high-dose, EKG-gated CT with contrast Comparing aortic diameters from the two protocols.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measures validity (aorta diameter in mm from scan images)	Comparing aorta diameters from the two modalities.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiation (in msev from scanner report)	Comparing radiation exposure with the two modalities	12 months

Collaborators and Investigators

• Sponsor: Université de Sherbrooke
• Investigators: Principal Investigator: Paul Farand, Université de Sherbrooke

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2017
• Primary Completion (Actual): April 30, 2019
• Study Completion (Actual): May 30, 2019

Study Registration Dates

• First Submitted: April 2, 2017
• First Submitted That Met QC Criteria: April 8, 2017
• First Posted (Actual): April 13, 2017

Study Record Updates

• Last Update Posted (Actual): July 18, 2019
• Last Update Submitted That Met QC Criteria: July 17, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm
• Other Study ID Numbers: 2016-1074

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
• product manufactured in and exported from the U.S.: No