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Non Invasive Imaging of Abdominal Aorta Aneurysm Hemodynamics and Wall Structure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01104688
First Posted: April 15, 2010
Last Update Posted: January 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nikolaj Eldrup, Aarhus University Hospital
  Purpose
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.

Condition
Aortic Aneurysm, Abdominal

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Non Invasive in Vivo Evaluation of Abdominal Aorta Aneurysm Hemodynamics, Wall Stress, and Inflammation Using Magnetic Resonance Imaging

Resource links provided by NLM:


Further study details as provided by Nikolaj Eldrup, Aarhus University Hospital:

Primary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: March 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Twenty patients diagnosed with an infrarenal abdominal aorta aneurysm will be selected from our clinical database.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01104688


Locations
Denmark
Aarhus University, Skejby Hospital, Department of cardiothoracic and vascular surgery & MR-center
Aarhus, Denmark, 8000
Sponsors and Collaborators
Aarhus University Hospital
Investigators
Principal Investigator: Jacob W Budtz-Lilly, MD Aarhus University Hospital Skejby, Department of cardiothoracic and vascular surgery
  More Information

Responsible Party: Nikolaj Eldrup, Counsultant MD PhD, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01104688     History of Changes
Other Study ID Numbers: M-20100008
First Submitted: April 14, 2010
First Posted: April 15, 2010
Last Update Posted: January 14, 2015
Last Verified: January 2015

Keywords provided by Nikolaj Eldrup, Aarhus University Hospital:
Abdominal Aortic Aneurysm
Wall Stress
Shear Stress
Inflammation
Magnetic Resonance Imaging

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases