Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000244808
Ethics application status
Approved
Date submitted
3/02/2012
Date registered
28/02/2012
Date last updated
1/03/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Screening for Abdominal Aortic Aneurysms: Improved detection by targeting high risk individuals.
Scientific title
Does ultrasound screening of cardiovascular disease patients result in improved Abdominal Aortic Aneurysm detection rates in comparison with an age & gender model?
Secondary ID [1] 279866 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
abdominal aortic aneurysm 285774 0
Condition category
Condition code
Cardiovascular 285946 285946 0 0
Diseases of the vasculature and circulation including the lymphatic system
Public Health 285947 285947 0 0
Epidemiology
Public Health 285948 285948 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A single transcutaneous ultrasound (US) scan of the abdomen will be performed to assess the presence or absence of abdominal aortic aneurysm (AAA). A blood sample will also be taken for analysis of genetic and biomarkers associated with AAA and other cardiovascular disease. This is a single consultation of approximately 20 minutes duration.
Intervention code [1] 284190 0
Not applicable
Comparator / control treatment
Local historical AAA rates (~2% in healthy elderly (mean age 69) males (from the Dunedin based Vascular Assessment Laboratory (University of Otago), 2002-2011) In addition, this rate will be compared with New Zealand incidence data from 2000-2008 (Sandiford etal. British Journal of Surgery 2011; 98: 645–651) and the United Kingdom 2009-2010 data (Conway etal. British Journal of Surgery 2012; 99: 73–77)
Control group
Historical

Outcomes
Primary outcome [1] 286433 0
Primary Outcome 1: to determine the prevalence of Abdominal Aortic Aneurysm in a screening population based on Cardiovascular disease risk. Test used: Transcutaneous ultrasound measured infra-renal abdominal aortic maximum diameter greater than or equal to 3cm
Timepoint [1] 286433 0
at time of screening
Primary outcome [2] 286434 0
Primary Outcome 2: to describe an Abdominal Aortic Aneurysm risk algorithm to optimise screening. Test used: Multiple logistic regression modeling to identify the most at risk subgroups.
Timepoint [2] 286434 0
post-screening (within 6 months of completing study recruitment)
Primary outcome [3] 286435 0
Primary Outcome 3: to test the feasibility of implementing Abdominal Aortic Aneurysm screening through primary and secondary care Cardiovascular disease healthcare providers. Test used: a statistical comparison of the historical age and gender based AAA rate with the two proposed screening models
Timepoint [3] 286435 0
post-screening (within 6 months of completing study recruitment)
Secondary outcome [1] 295888 0
To identify genetic and biomarkers of Abdominal Aortic Aneurysm risk susceptibility
Timepoint [1] 295888 0
Blood samples drawn at time of screening, analysis within 1 year of completing study recruitment

Eligibility
Key inclusion criteria
Clinically documented cardiovascular disease (CVD);
or
Elevated cardiovascular disease risk factors (Heart Foundation CVD score of moderate (15-20%) 5-year event risk or higher).
Minimum age
50 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age <50 years as Abdominal Aortic Aneurysm seldom develops before this age.
Age >90yrs as treatment options are limited and the risk of rupture is likely to be less than the risk of surgical repair.

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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2000
Accrual to date
Final
Recruitment outside Australia
Country [1] 4104 0
New Zealand
State/province [1] 4104 0

Funding & Sponsors
Funding source category [1] 284638 0
University
Name [1] 284638 0
Dept of Surgical Sciences, Dunedin School of Medicine, University of Otago
Country [1] 284638 0
New Zealand
Funding source category [2] 284639 0
Charities/Societies/Foundations
Name [2] 284639 0
HealthCare Otago Charitable Trust
Country [2] 284639 0
New Zealand
Primary sponsor type
University
Name
Department of Surgical Sciences, Dunedin School of Medicine, University of Otago
Address
P.O. Box 913, Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 283551 0
None
Name [1] 283551 0
Address [1] 283551 0
Country [1] 283551 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286628 0
Upper South A Regional Ethics Committee (NZ)
Ethics committee address [1] 286628 0
Ethics committee country [1] 286628 0
New Zealand
Date submitted for ethics approval [1] 286628 0
06/11/2011
Approval date [1] 286628 0
26/01/2012
Ethics approval number [1] 286628 0
URA/11/11/072

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33730 0
Address 33730 0
Country 33730 0
Phone 33730 0
Fax 33730 0
Email 33730 0
Contact person for public queries
Name 16977 0
Professor Andre van Rij
Address 16977 0
Department of Surgical Sciences
Dunedin School of Medicine
University of Otago
P.O. Box 913
Dunedin 9054
Country 16977 0
New Zealand
Phone 16977 0
+64 3 4740999
Fax 16977 0
Email 16977 0
[email protected]
Contact person for scientific queries
Name 7905 0
Professor Andre van Rij
Address 7905 0
Department of Surgical Sciences
Dunedin School of Medicine
University of Otago
P.O. Box 913
Dunedin 9054
Country 7905 0
New Zealand
Phone 7905 0
+64 3 4740999
Fax 7905 0
Email 7905 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.