Magnetic Resonance Elastography in Patients With Abdominal Aortic Aneurysms
Part of paid clinical trials in Columbus, Ohio.
- Sponsor
- Ohio State University
- Study ID
- NCT02387255
- Status
- Recruiting
Conditions
- Abdominal Aortic Aneurysm
Eligibility Criteria
- Sex
- ALL
- Age
- 20 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- 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.
Study Details
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.
Key Dates
- Start date
- Oct 31, 2014
- Status verified
- Apr 2025
- Primary completion
- Oct 31, 2028
- Completion
- Oct 31, 2028
Study Design
- Enrollment
- 165 participants (estimated)
Arms
- Arm: Normal Volunteers60 normal volunteers will be recruited. Each volunteer will undergo a single MRE scan (with Resoundant driver System ) of their abdominal aorta.
- Arm: Patients with AAAFifty to sixty five patients with AAA will be recruited. These patients will undergo MRE (with Resoundant driver system) of their AAA every six months for three years, or until the study ends or until the time of surgical repair or death due to rupture of AAA or other causes.
- Arm: Open Surgical Repair PatientsFifty to sixty five patients patients undergoing open surgical repair will be recruited and undergo MRE (with Resoundant driver system) prior to surgery
Primary Outcome Measure
MRE-Derived Shear Stiffness in kPa [ Time Frame: Upto 36 months at every 6 months ]
Central Contacts
- Kristin L Thompson, B.S.614-366-5429
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The Ohio State University Medical Center | Columbus | Ohio | 43210 | Arunark Kolipaka, PhD (PRINCIPAL_INVESTIGATOR) |
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