Estimation of Biomechanical Aortic Wall Properties in Healthy and Aneurysmal Aortas Using Novel Imaging Techniques
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ECHO, ECG-gated MRA.
- Who it may be relevant to
- Registry conditions: Abdominal Aortic Aneurysm. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Device ECHO
Imaging - Device ECG-gated MRA
Imaging
Primary outcome measures
- ECHO Imaging [Time frame: Change from baseline in ECHO imaging measurements]
Secondary outcome measures (1)
- ECG-gated MRA Imaging [Time frame: Change from baseline ECG-gated imaging measurements.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Mayo Clinic Florida — Jacksonville
Identifiers
NCT: NCT02548546 · 14-004151