Non Invasive Imaging of Abdominal Aorta Aneurysm Hemodynamics and Wall Structure

Aortic Aneurysm, Abdominal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01104688
• Other study ID #: M-20100008
• Status: Completed
• Phase: N/A
• First received: April 14, 2010
• Last updated: January 12, 2015
• Start date: March 2010
• Est. completion date: March 2012

Study information

• Verified date: January 2015
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

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 Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Locations

Country	Name	City	State
Denmark	Aarhus University, Skejby Hospital, Department of cardiothoracic and vascular surgery & MR-center	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		12 Months	No