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NCT Number: NCT02548546

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location status: Recruiting

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Echo

Device

Imaging

ECG-gated MRA

Device

Imaging

Primary outcomes

  1. ECHO Imaging

    Time frame: Change from baseline in ECHO imaging measurements

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

Secondary outcomes

  1. ECG-gated MRA Imaging

    Time frame: Change from baseline ECG-gated imaging measurements.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Houssam Farres, MD

CONTACT

[email protected]

904-953-2077

Mauricia Buchanan, RN

CONTACT

[email protected]

904-953-2077

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2015
Primary completion
2026
Study completion
2026
First posted
Sep 14, 2015
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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