Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000117617
Ethics application status
Approved
Date submitted
5/08/2005
Date registered
9/08/2005
Date last updated
4/04/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Endoluminal Aneurysm Repair Surveillance
Scientific title
A double blind study to compare the use of duplex ultrasound to the gold standard computed tomography for the surveillance of endoluminal aneurysm repair
Secondary ID [1] 108 0
Repatriation General Hospital: 73/04
Secondary ID [2] 109 0
University of South Australia: HS35-2004
Universal Trial Number (UTN)
Trial acronym
EARS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endoluminal Aneurysm repair 205 0
Condition category
Condition code
Cardiovascular 229 229 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Prospective double blind study

Particapants undergo computed tomography and two duplex ultrasound scans on the same day
The study involves direct comparison between the computed tomography and duplex findings in regard to maximum aneurysm diameter correlation, edoleak detection and classification and graft patency. The study began in Feburary 2005 for 1 year duration
Intervention code [1] 129 0
Diagnosis / Prognosis
Comparator / control treatment
Quasi experimental as the participants act as their own control group.
Control group
Active

Outcomes
Primary outcome [1] 276 0
Assess the accuracy of duplex ultrasound for the evaluation of endoleaks, aneurysm sac size and graft patency compared to the gold standard Computed Tomography (CT).
Timepoint [1] 276 0
Measured once on the day they participate in study
Secondary outcome [1] 620 0
Record patients weight and height to calculate BMI to see if there is a maximum BMI where ultrasound can be used.
Timepoint [1] 620 0
Measured once on the day they participate in study

Eligibility
Key inclusion criteria
Patients who have had their AAA repaired with a Cook Zenith graft
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/02/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 290 0
Commercial sector/Industry
Name [1] 290 0
Repat Radiology
Country [1] 290 0
Australia
Funding source category [2] 3129 0
Commercial sector/Industry
Name [2] 3129 0
repat radiology
Country [2] 3129 0
Australia
Primary sponsor type
Hospital
Name
Repat Radiology, Repatriation General Hospital
Address
daws road
daw park sa 5041
Country
Australia
Secondary sponsor category [1] 221 0
None
Name [1] 221 0
None
Address [1] 221 0
Country [1] 221 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1144 0
Repatriation general Hospital
Ethics committee address [1] 1144 0
Ethics committee country [1] 1144 0
Australia
Date submitted for ethics approval [1] 1144 0
Approval date [1] 1144 0
Ethics approval number [1] 1144 0
Ethics committee name [2] 1145 0
University of South Australia
Ethics committee address [2] 1145 0
Ethics committee country [2] 1145 0
Australia
Date submitted for ethics approval [2] 1145 0
Approval date [2] 1145 0
Ethics approval number [2] 1145 0

Summary
Brief summary
Endoluminal repair of abdominal aortic aneurysm (enlargement of the main artery) is a relatively new procedure whic requires long term follow-up. This is usually done with computed tomography which has the disadvantages of repeated dose of contrast agents and radiation. We believe ultrasound can be used to follow-up patients after endoluminal repair with out any harmful effects.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35193 0
Address 35193 0
Country 35193 0
Phone 35193 0
Fax 35193 0
Email 35193 0
Contact person for public queries
Name 9318 0
Jodie Graham
Address 9318 0
Repatriation Radiology
Repatriation general Hospital
Daws Road
Daw Park SA 5041
Country 9318 0
Australia
Phone 9318 0
+61 8 82751605
Fax 9318 0
+61 8 82751116
Email 9318 0
jodie.graham@rgh.sa.gov.au
Contact person for scientific queries
Name 246 0
Jodie Graham
Address 246 0
Repatriation Radiology
Repatriation General Hospital
Daws Road
Daw Park SA 5041
Country 246 0
Australia
Phone 246 0
+61 8 82751605
Fax 246 0
+61 8 82751116
Email 246 0
jodie.graham@rgh.sa.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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