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

Ascendant Aortic Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03113539
• Other study ID #: 2016-1074
• Status: Completed
• Phase: N/A
• Start date: April 12, 2017
• Est. completion date: May 30, 2019

Study information

• Verified date: July 2019
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: May 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 100 Years

Eligibility

Inclusion Criteria:

• 60 years old and more

• 85 bpm or less

Exclusion Criteria:

• aortic material

• EKG gating not possible

• aorta pathology (thrombus, dissection)

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Ascendant Aortic Aneurysm

Intervention

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.

Locations

Country	Name	City	State
Canada	Sherbrooke University Hospital	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measures validity (aorta diameter in mm from scan images)	Comparing aorta diameters from the two modalities.	12 months
Secondary	Radiation (in msev from scanner report)	Comparing radiation exposure with the two modalities	12 months