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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • ECHO

    Device

    Imaging

  • ECG-gated MRA

    Device

    Imaging

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: SurveillanceActive comparator 2 interventions
Group B: Surgery-OpenActive comparator 2 interventions
Group C: Surgery-EVARActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

ECHO Imaging

Imaging taken of the aneurysm, locating peak wall stress and measuring percent of strain per seconds.

Time frame
Change from baseline in ECHO imaging measurements

Secondary outcomes

1

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.

Time frame
Change from baseline ECG-gated imaging measurements.

Other outcomes

Sponsors and contacts

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