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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2026-08-31

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.

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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).

Conditions

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Abdominal Aortic Aneurysm

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Surveillance

No Surgery with ECHO and ECG-gated MRA imaging.

Group Type ACTIVE_COMPARATOR

ECHO

Intervention Type DEVICE

Imaging

ECG-gated MRA

Intervention Type DEVICE

Imaging

Surgery-Open

Open Surgery with ECHO and ECG-gated MRA imaging.

Group Type ACTIVE_COMPARATOR

ECHO

Intervention Type DEVICE

Imaging

ECG-gated MRA

Intervention Type DEVICE

Imaging

Surgery-EVAR

EVAR with ECHO and ECG-gated MRA imaging.

Group Type ACTIVE_COMPARATOR

ECHO

Intervention Type DEVICE

Imaging

ECG-gated MRA

Intervention Type DEVICE

Imaging

Interventions

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ECHO

Imaging

Intervention Type DEVICE

ECG-gated MRA

Imaging

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No