NCT02875444

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 23, 2016

Completed
Last Updated

September 7, 2016

Status Verified

September 1, 2016

Enrollment Period

4 months

First QC Date

August 18, 2016

Last Update Submit

September 6, 2016

Conditions

Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (1)

  • Maximum diameter of abdominal aortic aneurysm

    Maximum abdominal aortic aneurysm measured using 11 measurement methods

    Day 0

Study Arms (1)

group "abdominal aortic aneurysm"

Patients with non-operated abdominal aortic aneurysm with angio-CT realized between 01/01 2010 au 04/15/2012

Other: Angio-CT

Interventions

Angio-CTOTHER
group "abdominal aortic aneurysm"

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with non-opered abdominal aortic aneurysm with angio-CT realized between 01/01 2010 au 04/15/2012

You may qualify if:

  • patients with abdominal aortic aneurysm

You may not qualify if:

  • inflammatory aneurysm
  • false aneurysm
  • aneurysm after open repair or stent graft

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu de Reims

Reims, France, 51092, France

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2016

First Posted

August 23, 2016

Study Start

January 1, 2013

Primary Completion

May 1, 2013

Study Completion

December 1, 2013

Last Updated

September 7, 2016

Record last verified: 2016-09

Locations

FR(1)