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OpenTrials
Completed

NCT Number: NCT01104688

Non Invasive Imaging of Abdominal Aorta Aneurysm Hemodynamics and Wall Structure

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.

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Key information

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Aarhus, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Apr 15, 2010
Registry last updated
Jan 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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