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

Not Applicable

Recruiting

• Conditions: Abdominal Aortic Aneurysm
• Interventions: Device: ECHO; Device: ECG-gated MRA

• Registration Number: NCT02548546
• Lead Sponsor: Mayo Clinic

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).

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-26
• Study First Submitted QC: 2015-09-10
• Study First Posted: 2015-09-14
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-10
• Last Update Posted: 2023-10-11
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgery-EVAR	ECHO	EVAR with ECHO and ECG-gated MRA imaging.
Surgery-EVAR	ECG-gated MRA	EVAR with ECHO and ECG-gated MRA imaging.
Surveillance	ECG-gated MRA	No Surgery with ECHO and ECG-gated MRA imaging.
Surgery-Open	ECG-gated MRA	Open Surgery with ECHO and ECG-gated MRA imaging.
Surgery-Open	ECHO	Open Surgery with ECHO and ECG-gated MRA imaging.
Surveillance	ECHO	No Surgery with ECHO and ECG-gated MRA imaging.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
ECG-gated MRA Imaging	Change 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.

Trial Locations

Locations (1)

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States