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

Mayo Clinic

Status: Enrolling

Conditions: Abdominal Aortic Aneurysm

Treatments: Device: ECG-gated MRA; Device: ECHO

Study type: Interventional

Funder types: Other

Identifiers

NCT02548546

14-004151

Details and patient eligibility

About

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.

Full 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).

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Surveillance

Active Comparator group

Description:

No Surgery with ECHO and ECG-gated MRA imaging.

Treatment:

Device: ECHO

Device: ECG-gated MRA

Surgery-Open

Active Comparator group

Description:

Open Surgery with ECHO and ECG-gated MRA imaging.

Treatment:

Device: ECHO

Device: ECG-gated MRA

Surgery-EVAR

Active Comparator group

Description:

EVAR with ECHO and ECG-gated MRA imaging.

Treatment:

Device: ECHO

Device: ECG-gated MRA