Aortic Distensibility (FAMRI)

November 7, 2012 updated by: Mayo Clinic

ECG-Gated Multidetector CT of Aortic Distensibility FAMRI

Can software be developed to automatically aid in the measurement of abdominal aortic aneurysms, and is there a way to predict future rupture or growth of abdominal aortic aneurysms.

Study Overview

Status

Completed

Conditions

Detailed Description

Hypothesis: ECG-gated multidetector CT and ECG-gated Dual Source CT can be used to create multiple volumetric datasets of the abdominal aorta over the time period of the cardiac cycle, allowing for direct and regional calculations of abdominal aortic distensibility over the entire volume of the abdominal aorta, providing insight into risk of abdominal aortic aneurysm rupture and early large vessel stiffness.

Study Type

Observational

Enrollment (Actual)

67

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing imaging of their abdominal aortic aneurysm

Description

Inclusion Criteria:

  • AAA must be at least 3 cm to a maximum 4.9cm cross-sectional diameter.
  • BMI 31 or less.
  • Creatinine results <2.0 and within six months prior to scan.
  • US patients must have only normal creatinine (0.9 to 1.4) for one year before study visit.
  • Patients who are originally scheduled for US, who are then subsequently rolled in this study, will have only a ultrasound scan as followup after the initial CTA.

Exclusion Criteria:

  • Creatinine > 2.0.
  • Creatinine <0.9 or >1.4 for those who are scheduled for US.
  • Atrial fibrillation or other arrythmia.
  • Known AAA greater than 5 cm in size.
  • Allergy to contrast dye.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Aortic aneurysm repair
2
Aortic aneurysm growth
3
Aortic aneurysm growth stable.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
In year one, this data will be used to develop pulsatility software and test robustness.
Time Frame: First Year
First Year

Secondary Outcome Measures

Outcome Measure
Time Frame
In year two, the time-resolved CT angiographic datasets from each patient will be analyzed to determine peak AAA pulsatility and peak AAA relative pulsatility (to cross-sectional area within the aneurysm).
Time Frame: Year Two
Year Two

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

Flight Attendant Medical Research Institute

Investigators

  • Principal Investigator: Joel G. Fletcher, M.D., Mayo Clinic - Rochester, Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

December 22, 2007

First Submitted That Met QC Criteria

January 7, 2008

First Posted (Estimate)

January 8, 2008

Study Record Updates

Last Update Posted (Estimate)

November 9, 2012

Last Update Submitted That Met QC Criteria

November 7, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1994-04
  • 2A3360
  • FAMRI 2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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