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.

Study Overview

• Status: Recruiting
• Conditions: Abdominal Aortic Aneurysm
• Intervention / Treatment: Device: ECHO; Device: ECG-gated MRA

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).

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Houssam Farres, MD; Phone Number: 904-953-2077; Email: farres.houssam@mayo.edu
• Study Contact Backup: Name: Mauricia Buchanan, RN; Phone Number: 904-953-2077; Email: buchanan.mauricia@mayo.edu

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Surveillance; No Surgery with ECHO and ECG-gated MRA imaging.	Device: ECHO; Imaging; Device: ECG-gated MRA; Imaging
Active Comparator: Surgery-Open; Open Surgery with ECHO and ECG-gated MRA imaging.	Device: ECHO; Imaging; Device: ECG-gated MRA; Imaging
Active Comparator: Surgery-EVAR; EVAR with ECHO and ECG-gated MRA imaging.	Device: ECHO; Imaging; Device: ECG-gated MRA; Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ECHO Imaging	Imaging taken of the aneurysm, locating peak wall stress and measuring percent of strain per seconds.	Change from baseline in ECHO imaging measurements

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from baseline ECG-gated imaging measurements.

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Houssam Farres, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: August 26, 2015
• First Submitted That Met QC Criteria: September 10, 2015
• First Posted (Estimated): September 14, 2015

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: September 9, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: 14-004151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO