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Aortic Distensibility

NCT ID: NCT00587977

Last Updated: 2012-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

67 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-11-30

Study Completion Date

2009-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Abdominal Aortic Aneurysm

Keywords

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Abdominal aortic aneurysm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Aortic aneurysm repair

No interventions assigned to this group

2

Aortic aneurysm growth

No interventions assigned to this group

3

Aortic aneurysm growth stable.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Flight Attendant Medical Research Institute

OTHER

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Mayo Clinic Rochester, Minnesota

Principal Investigators

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Joel G. Fletcher, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic - Rochester, Minnesota

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 17885194 (View on PubMed)

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

Reference Type BACKGROUND

Other Identifiers

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2A3360

Identifier Type: -

Identifier Source: secondary_id

FAMRI 2

Identifier Type: -

Identifier Source: secondary_id

1994-04

Identifier Type: -

Identifier Source: org_study_id