Magnetic Resonance Elastography in Patients With Abdominal Aortic Aneurysms
ConditionAbdominal Aortic Aneurysm
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20+
SponsorOhio State University
About this trial
The main objective of this study is to utilize Magnetic Resonance Elastography (MRE) to determine tissue stiffness of abdominal aortic aneurysms (AAA). For patients with AAA, MRE is a more sensitive and superior method of determining the risk for rupture of AAA based on stiffness estimates when compared to the current, crude method of assessing risk based on measurement of the diameter of the aneurysm. The investigators will also validate the stiffness estimates against gold standard i.e. mechanical testing and histopathology only AAA patients undergoing AAA surgery.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Must be able to lie flat on their back in the scanner for up to 60 minutes
Must be able to hold breath for up to 15 seconds
Disqualifiers
Patients who are claustrophobic
Patients who are pregnant
Patients with any unapproved, non-MRI save metal/devices in or on their body
Trial population
1. Normal volunteers are control group 2. Patients who are being monitored for diameter of AAA 3. Patients who will undergo surgical repair of AAA
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Resoundant Driver System
DeviceThis device is used to generate vibrations at the area of interest. The device has an active driver, a loud speaker sitting outside the scanner area, and a passive driver, which is shaped like a silicone paddle, which is secured with velcro straps to the area being imaged. Sound waves from the active driver travel through a tube attached to the passive driver and generate vibrations, images of which are captured by the MR scanner.
Treatment groups
165 Participants
are divided into 3 treatment groupsGroup A: Normal Volunteers1 intervention
Group B: Patients with AAA1 intervention
Group C: Open Surgical Repair Patients1 intervention
Trial outcomes
Primary outcomes
1
MRE-Derived Shear Stiffness in kPa
Use of MRE stiffness estimates to determine rupture
Time frame
Upto 36 months at every 6 monthsSponsors and contacts
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Source ClinicalTrials.gov