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

NCT ID: NCT03113539

Last Updated: 2019-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-12

Study Completion Date

2019-05-30

Brief Summary

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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

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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.

Conditions

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Ascendant Aortic Aneurysm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Modified Low-dose, EKG-gated CT without contrast for the evaluation of aortic aneurysm

Intervention Type OTHER

On the same day, the subject will do :

1. Modified low-dose, EKG-gated CT without contrast
2. Usual high-dose, EKG-gated CT with contrast

Comparing aortic diameters from the two protocols.

Interventions

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Modified Low-dose, EKG-gated CT without contrast for the evaluation of aortic aneurysm

On the same day, the subject will do :

1. Modified low-dose, EKG-gated CT without contrast
2. Usual high-dose, EKG-gated CT with contrast

Comparing aortic diameters from the two protocols.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 60 years old and more
* 85 bpm or less

Exclusion Criteria

* aortic material
* EKG gating not possible
* aorta pathology (thrombus, dissection)
Minimum Eligible Age

60 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Université de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

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Paul Farand

MD, FRCPC, Professeur agréé, Directeur du service de cardiologie

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paul Farand

Role: PRINCIPAL_INVESTIGATOR

Université de Sherbrooke

Locations

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Sherbrooke University Hospital

Sherbrooke, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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2016-1074

Identifier Type: -

Identifier Source: org_study_id

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