Clinical trial NCT01104688: Non Invasive Imaging of Abdominal Aorta Aneurysm Hemodynamics and Wall Structure
Official title: Non Invasive in Vivo Evaluation of Abdominal Aorta Aneurysm Hemodynamics, Wall Stress, and Inflammation Using Magnetic Resonance Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Aneurysm, Abdominal
Keywords: Abdominal Aortic Aneurysm
Wall Stress
Shear Stress
Inflammation
Magnetic Resonance Imaging
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2010-04-15
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Twenty patients diagnosed with an infrarenal abdominal aorta aneurysm will be selected from our clinical database.

Brief summary: 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: 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 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

Primary outcomes:
measure: 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.
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University, Skejby Hospital, Department of cardiothoracic and vascular surgery & MR-center
Study officials:
affiliation: Aarhus University Hospital Skejby, Department of cardiothoracic and vascular surgery
name: Jacob W Budtz-Lilly, MD
role: PRINCIPAL_INVESTIGATOR
References: