Low-dose Gated CT Validity for the Evaluation of Ascendant Aortic Aneurysm.
Primary Purpose
Ascendant Aortic Aneurysm
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Modified Low-dose, EKG-gated CT without contrast for the evaluation of aortic aneurysm
Sponsored by
About this trial
This is an interventional other trial for Ascendant Aortic Aneurysm
Eligibility Criteria
Inclusion Criteria:
- 60 years old and more
- 85 bpm or less
Exclusion Criteria:
- aortic material
- EKG gating not possible
- aorta pathology (thrombus, dissection)
Sites / Locations
- Sherbrooke University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Subjects awaiting for an aortic evaluation
Arm Description
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.
Outcomes
Primary Outcome Measures
Measures validity (aorta diameter in mm from scan images)
Comparing aorta diameters from the two modalities.
Secondary Outcome Measures
Radiation (in msev from scanner report)
Comparing radiation exposure with the two modalities
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03113539
Brief Title
Low-dose Gated CT Validity for the Evaluation of Ascendant Aortic Aneurysm.
Official Title
Low-dose, EKG-gated CT Validity for the Evaluation of Ascendant Aortic Aneurysm.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
April 12, 2017 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
May 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sherbrooke
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ascendant Aortic Aneurysm
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subjects awaiting for an aortic evaluation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Modified Low-dose, EKG-gated CT without contrast for the evaluation of aortic aneurysm
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measures validity (aorta diameter in mm from scan images)
Description
Comparing aorta diameters from the two modalities.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Radiation (in msev from scanner report)
Description
Comparing radiation exposure with the two modalities
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
60 years old and more
85 bpm or less
Exclusion Criteria:
aortic material
EKG gating not possible
aorta pathology (thrombus, dissection)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Farand
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sherbrooke University Hospital
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H5N4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Low-dose Gated CT Validity for the Evaluation of Ascendant Aortic Aneurysm.
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