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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Abdominal Aortic Aneurysm

Intervention / Treatment
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* Device: ECHO
* Device: ECG-gated MRA


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Surveillance<br>No Surgery with ECHO and ECG-gated MRA imaging. | Device: ECHO<br>* Imaging<br>Device: ECG-gated MRA<br>* Imaging<br>|
| Active Comparator: Surgery-Open<br>Open Surgery with ECHO and ECG-gated MRA imaging. | Device: ECHO<br>* Imaging<br>Device: ECG-gated MRA<br>* Imaging<br>|
| Active Comparator: Surgery-EVAR<br>EVAR with ECHO and ECG-gated MRA imaging. | Device: ECHO<br>* Imaging<br>Device: ECG-gated MRA<br>* Imaging<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ECHO Imaging | Imaging taken of the aneurysm, locating peak wall stress and measuring percent of strain per seconds. | Change from baseline in ECHO imaging measurements | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ECG-gated MRA Imaging | The MRA imaging will be taken with the ECG-gating to synchronize the timing of the image acquisition with cardiac motion. This will allow for more accurate measurement of vessel diameter measured in mm (millimeters) and reported in percent change from baseline. | Change from baseline ECG-gated imaging measurements. |