Aortic Distensibility (FAMRI)

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. Read our disclaimer for details. Identifier: NCT00587977
Recruitment Status : Completed
First Posted : January 8, 2008
Last Update Posted : November 9, 2012
Flight Attendant Medical Research Institute
Information provided by:
Mayo Clinic

Brief Summary:
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.

Condition or disease
Abdominal Aortic Aneurysm

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
Actual Enrollment : 67 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: ECG-Gated Multidetector CT of Aortic Distensibility FAMRI
Study Start Date : November 2004
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Aortic aneurysm repair
Aortic aneurysm growth
Aortic aneurysm growth stable.

Primary Outcome Measures :
  1. In year one, this data will be used to develop pulsatility software and test robustness. [ Time Frame: First Year ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing imaging of their abdominal aortic aneurysm

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.

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 identifier (NCT number): NCT00587977

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Flight Attendant Medical Research Institute
Principal Investigator: Joel G. Fletcher, M.D. Mayo Clinic - Rochester, Minnesota

Additional Information:
Wentz RJ, Manduca A, Fletcher JG, Siddiki HA, Shields RC, Vrtiska TJ, Spencer GC, Primak AN, Zhang J, Nielson TA, McCollough CH, Yu L. SPIE Medical Imaging 2007.: Physiology, Function, and Structure from Medical Images, 2007; 6511:1-9

Responsible Party: Joel Garland Fletcher, M.D., Mayo Clinic Rochester, Minnesota Identifier: NCT00587977     History of Changes
Other Study ID Numbers: 1994-04
First Posted: January 8, 2008    Key Record Dates
Last Update Posted: November 9, 2012
Last Verified: November 2012

Keywords provided by Mayo Clinic:
Abdominal aortic aneurysm

Additional relevant MeSH terms:
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases