Aortic Distensibility
FAMRI
ECG-Gated Multidetector CT of Aortic Distensibility FAMRI
3 other identifiers
observational
67
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2004
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 22, 2007
CompletedFirst Posted
Study publicly available on registry
January 8, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedNovember 9, 2012
November 1, 2012
4.7 years
December 22, 2007
November 7, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
In year one, this data will be used to develop pulsatility software and test robustness.
First Year
Secondary Outcomes (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).
Year Two
Study Arms (3)
1
Aortic aneurysm repair
2
Aortic aneurysm growth
3
Aortic aneurysm growth stable.
Eligibility Criteria
Patients undergoing imaging of their abdominal aortic aneurysm
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- Flight Attendant Medical Research Institutecollaborator
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Related Publications (2)
Zhang J, Fletcher JG, Vrtiska TJ, Manduca A, Thompson JL, Raghavan ML, Wentz RJ, McCollough CH. Large-vessel distensibility measurement with electrocardiographically gated multidetector CT: phantom study and initial experience. Radiology. 2007 Oct;245(1):258-66. doi: 10.1148/radiol.2451060530.
PMID: 17885194BACKGROUNDWentz 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
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joel G. Fletcher, M.D.
Mayo Clinic - Rochester, Minnesota
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 22, 2007
First Posted
January 8, 2008
Study Start
November 1, 2004
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
November 9, 2012
Record last verified: 2012-11