Skip to content

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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02548546
Enrollment
30
Registered
2015-09-14
Start date
2015-08-31
Completion date
2026-08-31
Last updated
2025-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Aortic Aneurysm

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).

Interventions

DEVICEECHO

Imaging

DEVICEECG-gated MRA

Imaging

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
ECHO ImagingChange from baseline in ECHO imaging measurementsImaging taken of the aneurysm, locating peak wall stress and measuring percent of strain per seconds.

Secondary

MeasureTime frameDescription
ECG-gated MRA ImagingChange 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.

Countries

United States

Contacts

Primary ContactHoussam Farres, MD
farres.houssam@mayo.edu904-953-2077
Backup ContactMauricia Buchanan, RN
buchanan.mauricia@mayo.edu904-953-2077

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026