Estimation of Biomechanical Aortic Wall Properties in Healthy and Aneurysmal Aortas Using Novel Imaging Techniques

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Disease Information

Descriptive Information
Brief Title † Estimation of Biomechanical Aortic Wall Properties in Healthy and Aneurysmal Aortas Using Novel Imaging Techniques
Official Title † Estimation of Biomechanical Aortic Wall Properties in Healthy and Aneurysmal Aortas Using Novel Imaging Techniques
Brief Summary The primary aim of this study is to establish the practicality of using two novel imaging modalities for the assessment of biomechanical properties of the aorta.
Detailed Description Patients with Abdominal Aortic Aneurysm, (AAA), will be identified within the vascular surgery practice. Those patients who meet standard indications for surgery including symptomatic AAA, size >5.0-5.5 cm, or rapidly enlarging >0.5 cm per 6 months will have standard pre-operative work-up which includes magnetic resonance angiogram (MRA) and Echocardiogram (ECHO). These pre-operative studies will be modified for the study patients to include electrocardiogram(ECG)-gating (coupled with MR angiogram) and 2-Dimensional speckle-tracking ultrasound of the abdominal aorta. Patients in the study will be followed for 1 year. Measurements will be analyzed for any relationship between aortic wall properties and clinical outcomes such as aneurysm growth, rupture risk or aortic dissection. This study will be comparing 3 groups of patients: no surgery (surveillance), open surgery, and endovascular aneurysm repair (EVAR).
Study Phase N/A
Study Type † Interventional
Study Design † Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary Outcome Measure † ECHO Imaging
Secondary Outcome Measure † ECG-gated MRA Imaging
Condition † Abdominal Aortic Aneurysm
Intervention † DeviceECHO
Study Arms / Comparison Groups Surveillance No Surgery with ECHO and ECG-gated MRA imaging. Surgery-Open Open Surgery with ECHO and ECG-gated MRA imaging. Surgery-EVAR EVAR with ECHO and ECG-gated MRA imaging.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Device
Estimated Enrollment † 30
Start Date † August 2015
Completion Date August 2017
Primary Completion Date August 2017
Eligibility Criteria † Inclusion Criteria: - Patients >18 years of age with ability to provide informed consent. - Patients with either symptomatic or asymptomatic AAA as defined by aortic diameter ≥ 1.5x normal diameter. - Patients with non-aneurysmal aortas who require aortic contrast imaging or echocardiography for preoperative planning or other reason. Exclusion Criteria: - Patients with contraindication to IV contrast such as allergy or severe kidney dysfunction. - Patients who do not require contrast imaging or echocardiogram as part of their care plan. - Terminally ill patients, and patients with estimated life expectancy of ≤ 6 months. - Patients unable to tolerate magnetic resonance imaging.
Gender Both
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts †† Houssam Farres, MD, 904-953-2077,
Location Countries † United States
Administrative Information
NCT ID † NCT02548546
Organization ID 14-004151
Secondary IDs ††
Responsible Party Principal Investigator
Study Sponsor † Mayo Clinic
Collaborators ††
Investigators † : ,
Information Provided By
Verification Date September 2015
First Received Date † August 26, 2015
Last Updated Date September 10, 2015
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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