Estimation of Biomechanical Aortic Wall Properties in Healthy and Aneurysmal Aortas Using Novel Imaging Techniques
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 26, 2015
CompletedFirst Posted
Study publicly available on registry
September 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
September 11, 2025
September 1, 2025
11 years
August 26, 2015
September 9, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
ECG-gated MRA Imaging
Change from baseline ECG-gated imaging measurements.
Study Arms (3)
Surveillance
ACTIVE COMPARATORNo Surgery with ECHO and ECG-gated MRA imaging.
Surgery-Open
ACTIVE COMPARATOROpen Surgery with ECHO and ECG-gated MRA imaging.
Surgery-EVAR
ACTIVE COMPARATOREVAR with ECHO and ECG-gated MRA imaging.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Houssam Farres, MD
Mayo Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
August 26, 2015
First Posted
September 14, 2015
Study Start
August 1, 2015
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
September 11, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share