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 Type
Interventional
Primary Outcome
ECHO Imaging
Secondary Outcome
ECG-gated MRA Imaging
Condition
Abdominal Aortic Aneurysm
Intervention
ECHO
Study Arms / Comparison Groups
Surveillance
Description: No Surgery 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 2022
Primary Completion Date
August 2022
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
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Houssam Farres, MD, 904-953-2077, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02548546
Organization ID
14-004151
Responsible Party
Principal Investigator
Study Sponsor
Mayo Clinic
Study Sponsor
Houssam Farres, MD, Principal Investigator, Mayo Clinic
Verification Date
September 2020