Aortic Distensibility

Completed

• Conditions: Abdominal Aortic Aneurysm

• Registration Number: NCT00587977
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2007-12-22
• Study First Submitted QC: 2008-01-07
• Study First Posted: 2008-01-08
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-07
• Last Update Posted: 2012-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In year one, this data will be used to develop pulsatility software and test robustness.	First Year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States