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Aortic Distensibility (FAMRI)

This study has been completed.
Sponsor:
Collaborator:
Flight Attendant Medical Research Institute
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00587977
First received: December 22, 2007
Last updated: November 7, 2012
Last verified: November 2012
History of Changes
  Purpose

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
Abdominal Aortic Aneurysm

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: ECG-Gated Multidetector CT of Aortic Distensibility FAMRI

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • In year one, this data will be used to develop pulsatility software and test robustness. [ Time Frame: First Year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 67
Study Start Date: November 2004
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Aortic aneurysm repair
2
Aortic aneurysm growth
3
Aortic aneurysm growth stable.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing imaging of their abdominal aortic aneurysm

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00587977

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

Additional Information:
Mayo Clinic Clinical Trials  This link exits the ClinicalTrials.gov site

Publications:
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
ClinicalTrials.gov Identifier: NCT00587977     History of Changes
Other Study ID Numbers: 1994-04, 2A3360, FAMRI 2
Study First Received: December 22, 2007
Last Updated: November 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Abdominal aortic aneurysm

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

ClinicalTrials.gov processed this record on June 18, 2013