Aortic Distensibility

Abdominal Aortic Aneurysm Clinical Trial

— FAMRI  

Official title:

ECG-Gated Multidetector CT of Aortic Distensibility FAMRI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00587977
• Other study ID #: 1994-04
• Secondary ID: 2A3360FAMRI 2
• Status: Completed
• Phase: N/A
• First received: December 22, 2007
• Last updated: November 7, 2012
• Start date: November 2004
• Est. completion date: July 2009

Study information

• Verified date: November 2012
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Flight Attendant Medical Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (2)

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In year one, this data will be used to develop pulsatility software and test robustness.		First Year	No
Secondary	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	No

External Links

•   Mayo Clinic Clinical Trials