Non Invasive Imaging of Abdominal Aorta Aneurysm Hemodynamics and Wall Structure

January 12, 2015 updated by: Nikolaj Eldrup, Aarhus University Hospital

Non Invasive in Vivo Evaluation of Abdominal Aorta Aneurysm Hemodynamics, Wall Stress, and Inflammation Using Magnetic Resonance Imaging

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.

Study Overview

Status

Completed

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Aarhus, Denmark, 8000
        • Aarhus University, Skejby Hospital, Department of cardiothoracic and vascular surgery & MR-center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Twenty patients diagnosed with an infrarenal abdominal aorta aneurysm will be selected from our clinical database.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Left ventricular longitudinal strain for perioperative cardiac monitoring in aortic aneurysm surgery using transthoracic 2-dimensional echocardiography: a a feasibility and repeatability study.feasibility and repeatability study.
Time Frame: 12 Months
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jacob W Budtz-Lilly, MD, Aarhus University Hospital Skejby, Department of cardiothoracic and vascular surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

April 14, 2010

First Submitted That Met QC Criteria

April 14, 2010

First Posted (Estimate)

April 15, 2010

Study Record Updates

Last Update Posted (Estimate)

January 14, 2015

Last Update Submitted That Met QC Criteria

January 12, 2015

Last Verified

January 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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