Magnetic Resonance Elastography in Patients With Abdominal Aortic Aneurysms (AAA-MRE)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Currently, MRE is a clinical tool used to assess hepatic fibrosis at many institutions. MRE is superior to invasive techniques (i.e. biopsies) and mechanical testing in that it is noninvasive and can be performed in vivo under physiologic conditions. MRE could make diagnosing stiffness widely available and could revolutionize the diagnosis and treatment of numerous other diseases affecting stiffness of soft tissues.
Aortic wall "stiffness" is a fundamental biomechanical parameter that reflects the structural integrity of normal and aneurysmal aortic tissue. AAAs enlarge over time leading to sudden rupture and death in up to 90% of patients. Surgical or endovascular aneurysm repair (EVAR) is recommended for AAAs > 5.5 cm in diameter. However, previous studies have reported a high percentage (13%) of smaller AAAs (<5 cm) go on to rupture, and an even higher percentage (60%) of larger AAAs (>5 cm) remain stable. Despite the poor prognostic value of aortic diameter, it is still the primary parameter used to time surgical repair. It is known that changes in stiffness of AAA can reveal important information on extra-cellular matrix content; a key factor in the pathophysiological development of AAA and the risk for rupture. A non-invasive, spatially resolved estimate of aortic stiffness may provide a superior determinant of the risk for rupture compared to the currently used anatomical measures. The relationship between non-invasively measured wall stiffness (WS) and the structural integrity of the aortic wall must be further elucidated. Therefore, aortic MRE can be used as a noninvasive tool to estimate the stiffness of AAAs and can provide superior diagnostic and prognostic information in patients with developing AAA disease.
Entry to this study is open to men and women aged 18 years and older, and to all racial and ethnic subgroups. Two separate groups of patients with AAA will be recruited. One group will be patients who have been diagnosed with AAA and are monitored to observe the size of the AAA. The other group is comprised of patients who are scheduled for surgical repair of AAA.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Kristin L Thompson, B.S.
- Phone Number: 614-366-5429
- Email: Kristin.Thompson@osumc.edu
Study Locations
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Ohio
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Columbus, Ohio, United States, 43210
- Recruiting
- The Ohio State University Medical Center
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Contact:
- Kristin L Thompson, B.S.
- Phone Number: 614-366-5429
- Email: Kristin.Thompson@osumc.edu
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Principal Investigator:
- Arunark Kolipaka, PhD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
- Normal volunteers are control group
- Patients who are being monitored for diameter of AAA
- Patients who will undergo surgical repair of AAA
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients who are claustrophobic
- Patients who are pregnant
- Patients with any unapproved, non-MRI save metal/devices in or on their body
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Normal Volunteers
60 normal volunteers will be recruited.
Each volunteer will undergo a single MRE scan (with Resoundant driver System ) of their abdominal aorta.
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This 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.
Other Names:
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Patients with AAA
Fifty 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.
|
This 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.
Other Names:
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Open Surgical Repair Patients
Fifty to sixty five patients patients undergoing open surgical repair will be recruited and undergo MRE (with Resoundant driver system) prior to surgery
|
This 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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
MRE-Derived Shear Stiffness in kPa
Time Frame: Upto 36 months at every 6 months
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Use of MRE stiffness estimates to determine rupture
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Upto 36 months at every 6 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Arunark Kolipaka, PhD, The Ohio State University Medical Center Dept. of Radiology
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013H0416
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