Trial record 4 of 84 for:    Open Studies | "Aortic Aneurysm, Abdominal"

Non Invasive Imaging of Abdominal Aorta Aneurysm Hemodynamics and Wall Structure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Aarhus University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Nikolaj Eldrup, Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT01104688
First received: April 14, 2010
Last updated: January 18, 2012
Last verified: January 2012
  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 Aarhus University Hospital:

Estimated Enrollment: 20
Study Start Date: March 2010
Estimated Study Completion Date: March 2012
Estimated 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

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01104688

Contacts
Contact: Jacob W Budtz-Lilly, MD (45) 28147705 jacoblilly99@yahoo.dk
Contact: William Paaske, Professor (45) 89496990

Locations
Denmark
Aarhus University, Skejby Hospital, Department of cardiothoracic and vascular surgery & MR-center Recruiting
Aarhus, Denmark, 8000
Contact    (45) 89496990      
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

No publications provided

Responsible Party: Nikolaj Eldrup, Counsultant MD PhD, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01104688     History of Changes
Other Study ID Numbers: M-20100008
Study First Received: April 14, 2010
Last Updated: January 18, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

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

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

ClinicalTrials.gov processed this record on July 10, 2014