- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01104688
Non Invasive Imaging of Abdominal Aorta Aneurysm Hemodynamics and Wall Structure
January 12, 2015 updated by: Nikolaj Eldrup, Aarhus University Hospital
Non Invasive in Vivo Evaluation of Abdominal Aorta Aneurysm Hemodynamics, Wall Stress, and Inflammation Using Magnetic Resonance Imaging
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Aarhus, Denmark, 8000
- Aarhus University, Skejby Hospital, Department of cardiothoracic and vascular surgery & MR-center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Twenty patients diagnosed with an infrarenal abdominal aorta aneurysm will be selected from our clinical database.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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12 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jacob W Budtz-Lilly, MD, Aarhus University Hospital Skejby, Department of cardiothoracic and vascular surgery
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
March 1, 2012
Study Completion (Actual)
March 1, 2012
Study Registration Dates
First Submitted
April 14, 2010
First Submitted That Met QC Criteria
April 14, 2010
First Posted (Estimate)
April 15, 2010
Study Record Updates
Last Update Posted (Estimate)
January 14, 2015
Last Update Submitted That Met QC Criteria
January 12, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M-20100008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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