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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surveillance | Active Comparator | No Surgery with ECHO and ECG-gated MRA imaging. |
|
| Surgery-Open | Active Comparator | Open Surgery with ECHO and ECG-gated MRA imaging. |
|
| Surgery-EVAR | Active Comparator | EVAR with ECHO and ECG-gated MRA imaging. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECHO | Device | Imaging |
| |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Houssam Farres, MD | Contact | 904-953-2077 | farres.houssam@mayo.edu | |
| Mauricia Buchanan, RN | Contact | 904-953-2077 | buchanan.mauricia@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Houssam Farres, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Florida | Recruiting | Jacksonville | Florida | 32224 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ECG-gated MRA |
| Device |
Imaging |
|
| D001018 |
| Aortic Diseases |