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

Primary Purpose

Abdominal Aortic Aneurysm

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ECHO
ECG-gated MRA
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Abdominal Aortic Aneurysm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Surveillance

Surgery-Open

Surgery-EVAR

Arm Description

No Surgery with ECHO and ECG-gated MRA imaging.

Open Surgery with ECHO and ECG-gated MRA imaging.

EVAR with ECHO and ECG-gated MRA imaging.

Outcomes

Primary Outcome Measures

ECHO Imaging
Imaging taken of the aneurysm, locating peak wall stress and measuring percent of strain per seconds.

Secondary Outcome Measures

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.

Full Information

First Posted
August 26, 2015
Last Updated
October 10, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02548546
Brief Title
Estimation of Biomechanical Aortic Wall Properties in Healthy and Aneurysmal Aortas Using Novel Imaging Techniques
Official Title
Estimation of Biomechanical Aortic Wall Properties in Healthy and Aneurysmal Aortas Using Novel Imaging Techniques
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2015 (undefined)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysm

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surveillance
Arm Type
Active Comparator
Arm Description
No Surgery with ECHO and ECG-gated MRA imaging.
Arm Title
Surgery-Open
Arm Type
Active Comparator
Arm Description
Open Surgery with ECHO and ECG-gated MRA imaging.
Arm Title
Surgery-EVAR
Arm Type
Active Comparator
Arm Description
EVAR with ECHO and ECG-gated MRA imaging.
Intervention Type
Device
Intervention Name(s)
ECHO
Intervention Description
Imaging
Intervention Type
Device
Intervention Name(s)
ECG-gated MRA
Intervention Description
Imaging
Primary Outcome Measure Information:
Title
ECHO Imaging
Description
Imaging taken of the aneurysm, locating peak wall stress and measuring percent of strain per seconds.
Time Frame
Change from baseline in ECHO imaging measurements
Secondary Outcome Measure Information:
Title
ECG-gated MRA Imaging
Description
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.
Time Frame
Change from baseline ECG-gated imaging measurements.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Houssam Farres, MD
Phone
904-953-2077
Email
farres.houssam@mayo.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mauricia Buchanan, RN
Phone
904-953-2077
Email
buchanan.mauricia@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Houssam Farres, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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

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