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

Abdominal Aortic Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02548546
• Other study ID #: 14-004151
• Status: Recruiting
• Phase: N/A
• Start date: August 2015
• Est. completion date: August 2024

Study information

• Verified date: October 2023
• Source: Mayo Clinic
• Contact: Houssam Farres, MD
• Phone: 904-953-2077
• Email: farres.houssam[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Device:
• ECHO
Imaging
• ECG-gated MRA
Imaging

Locations

Country	Name	City	State
United States	Mayo Clinic Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.

External Links

•   Mayo Clinic Clinical Trials