Non Invasive Imaging of Abdominal Aorta Aneurysm Hemodynamics and Wall Structure

NCT ID: NCT01104688

Last Updated: 2015-01-14

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

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-03-31

Brief Summary

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The development of the abdominal aorta aneurysm is multifactorial. Through use of magnetic resonance imaging without contrast, this study will look closely at flow, the stresses hereby induced, as well as signs of inflammation in the vessel wall.

Detailed Description

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The etiology of the abdominal aorta aneurysm is complex and multi-factorial. Biomechanic and hemodynamic stress contributes to aneurysmal growth, and the relevance of inflammation is gaining in terms of pathological influence. The technical advances of imaging now enable one to utilize magnetic resonance in reconstructing aortal blood flow. Newer post-imaging software then enables one to perform complex data analysis, wherein shear and wall-stress can be calculated. The goal of this study is to analyze the aneurysms of twenty patients. Values will be obtained for shear and wall stress. Additionally, the utilization of short tau wave inversion recovery (STIR) sequences will be performed to evaluate the presence or absence of acute edema and inflammation of the region. It should also be noted that particular attention will be placed on the so-called "neck" of the aneurysm, where the aneurysm typically tapers into what is often regarded as normal aortic tissue. This region is important for both the placement of a surgical bypass prosthesis or a deployed stent graft.

Conditions

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Aortic Aneurysm, Abdominal

Study Design

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Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Infrarenal abdominal aorta aneurysm (AAA)

Exclusion Criteria

* Lack of signed, informed consent
* Pacemaker or other implanted metal prostheses
* Claustrophobia
* Dementia
* Diabetes Mellitus
* Thoracoabdominal aorta aneurysm, per Crawford/Safi criteria
* Ehlers-Danlos, Marfans, or other diagnosed connective tissue disease
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Nikolaj Eldrup

Counsultant MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jacob W Budtz-Lilly, MD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital Skejby, Department of cardiothoracic and vascular surgery

Locations

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Aarhus University, Skejby Hospital, Department of cardiothoracic and vascular surgery & MR-center

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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M-20100008

Identifier Type: -

Identifier Source: org_study_id

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