Abdominal Aortic AneurysmNCT02548546
Estimation of Biomechanical Aortic Wall Properties in Healthy and Aneurysmal Aortas Using Novel Imaging Techniques
A study testing ECHO and ECG-gated MRA in people with Abdominal Aortic Aneurysm, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- ECHO and ECG-gated MRA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic Florida
Jacksonville, Florida, 32224
About this study
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.
Read the 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).
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- ECHO, ECG-gated MRA
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECHODevice
Imaging
ECG-gated MRADevice
Imaging
| Study group | Role | What they receive |
|---|---|---|
| Surveillance | Active comparator | No Surgery with ECHO and ECG-gated MRA imaging. Receives: Device: ECHO; Device: ECG-gated MRA |
| Surgery-Open | Active comparator | Open Surgery with ECHO and ECG-gated MRA imaging. Receives: Device: ECHO; Device: ECG-gated MRA |
| Surgery-EVAR | Active comparator | EVAR with ECHO and ECG-gated MRA imaging. Receives: Device: ECHO; Device: ECG-gated MRA |
What is being measured
The primary outcome is the main question the study is designed to answer.
ECHO Imaging
Imaging taken of the aneurysm, locating peak wall stress and measuring percent of strain per seconds.
Measured: Change from baseline in ECHO imaging measurements
Secondary outcomes (1)
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.
Measured: Change from baseline ECG-gated imaging measurements.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Houssam Farres, M.D., Mayo Clinic
- Investigators
- Houssam Farres, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02548546
- Sponsor's protocol ID
- 14-004151
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2015
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Biomechanical Aortic Wall Properties in Healthy and Aneurysmal Aortas Using Novel Imaging Techniques
- ClinicalTrials.gov ID
- NCT02548546
- Acronym / sponsor ID
- 14-004151
- Conditions
- Abdominal Aortic Aneurysm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 14 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Surveillance | Active comparator | Device: ECHO, Device: ECG-gated MRANo Surgery with ECHO and ECG-gated MRA imaging. |
| Surgery-Open | Active comparator | Device: ECHO, Device: ECG-gated MRAOpen Surgery with ECHO and ECG-gated MRA imaging. |
| Surgery-EVAR | Active comparator | Device: ECHO, Device: ECG-gated MRAEVAR with ECHO and ECG-gated MRA imaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECHOImaging | Device | Surgery-EVAR, Surgery-Open, Surveillance |
| ECG-gated MRAImaging | Device | Surgery-EVAR, Surgery-Open, Surveillance |
Primary outcome
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.
1 secondary outcome
ECG-gated MRA Imaging
Time frame: Change from baseline ECG-gated imaging measurements.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Houssam Farres, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECHO and ECG-gated MRA in people with Abdominal Aortic Aneurysm, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Houssam Farres, MD (904-953-2077, farres.houssam@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ECHO Imaging (time frame: Change from baseline in ECHO imaging measurements). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.