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NCT02875444 Clinical Trial

Measurement of Maximum Diameter of Native Abdominal Aortic Aneurysm by Angio-CT

Abdominal Aortic Aneurysm Clinical Trial

— AAA-angioCT  

Official title:
Measurement of Maximum Diameter of Native Abdominal Aortic Aneurysm by Angio-computed Tomography

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02875444
Other study ID # 2015Ao001
Secondary ID
Status Completed
Phase N/A
First received August 18, 2016
Last updated September 6, 2016
Start date January 2013
Est. completion date December 2013

Study information
Verified date September 2016
Source CHU de Reims
Contact n/a
Is FDA regulated No
Health authority France: Commission nationale de l'informatique et des libertés
Study type Observational

Clinical Trial Summary

Screening for an abdominal aortic aneurysm, monitoring its growth and evaluation of its risk of rupture are based on the measure of its maximum diameter. The abdominal aortic aneurysm's treatment to prevent its rupture is recommended from a threshold of 50-55 mm in men and of 45-50 mm in women.

The importance of this measure for patient management justify a specific and homogeneous protocol of measure. However, the diversity of methods of measuring the maximum diameter with scanner and ultrasound was shown.

The impact of various angio-CT based measures of maximum AAA diameter, and the impact of reproducibility limits on the decision to operate have never been investigated.

Description:

The aims of the study were :

Analyze the consequences on clinical decisions of this wide choice of methodologies for measurement of abdominal aortic aneurysm maximum diameter when using angio-CT; Identify the method of measurement that yields the best agreement for patient management.

Recruitment information / eligibility
Status Completed
Enrollment 46
Est. completion date December 2013
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patients with abdominal aortic aneurysm

Exclusion Criteria:

- inflammatory aneurysm

- false aneurysm

- aneurysm after open repair or stent graft

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Other:
• Angio-CT

Locations
Country Name City State
France Chu de Reims Reims

Sponsors (1)
Lead Sponsor Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Maximum diameter of abdominal aortic aneurysm Maximum abdominal aortic aneurysm measured using 11 measurement methods Day 0 No
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