We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02548546
Recruitment Status : Recruiting
First Posted : September 14, 2015
Last Update Posted : October 7, 2022
Sponsor:
Information provided by (Responsible Party):
Houssam Farres, M.D., Mayo Clinic

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Abdominal Aortic Aneurysm Device: ECHO Device: ECG-gated MRA Not Applicable

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Estimation of Biomechanical Aortic Wall Properties in Healthy and Aneurysmal Aortas Using Novel Imaging Techniques
Study Start Date : August 2015
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Surveillance
No Surgery with ECHO and ECG-gated MRA imaging.
 Device: ECHO
Imaging

Device: ECG-gated MRA
Imaging
Active Comparator: Surgery-Open
Open Surgery with ECHO and ECG-gated MRA imaging.
 Device: ECHO
Imaging

Device: ECG-gated MRA
Imaging
Active Comparator: Surgery-EVAR
EVAR with ECHO and ECG-gated MRA imaging.
 Device: ECHO
Imaging

Device: ECG-gated MRA
Imaging


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. ECG-gated MRA Imaging [ Time Frame: 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02548546


Contacts
Layout table for location contacts
Contact: Houssam Farres, MD 904-953-2077 farres.houssam@mayo.edu
Contact: Mauricia Buchanan, RN 904-953-2077 buchanan.mauricia@mayo.edu

Locations
Layout table for location information
United States, Florida
Mayo Clinic Florida Recruiting
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
Layout table for investigator information
Principal Investigator: Houssam Farres, MD Mayo Clinic
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Houssam Farres, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02548546    
Other Study ID Numbers: 14-004151
First Posted: September 14, 2015    Key Record Dates
Last Update Posted: October 7, 2022
Last Verified: October 2022
Additional relevant MeSH terms:
Layout table for MeSH terms
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
 Vascular Diseases
Cardiovascular Diseases
Aortic Diseases