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
c/- Ministry of Health
Montgomery Watson Building
6 Hazeldean Road
Christchurch 8024
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
While NZ does not currently have an Abdominal Aortic Aneurysm (AAA) screening programme, internationally ultrasound screening programmes are generally offered to males aged 65 or greater. This excludes women and those who develop AAA at a younger age and have more to gain from early detection. Our previous studies have identified that people with a history of arterial disease have a significantly greater risk of developing AAA. This trial will prospectively screen individuals with arterial disease or elevated cardiovascular disease (CVD) risk to validate these findings. Recruitment and screening will be undertaken through existing primary and secondary CVD healthcare providers to assess whether or not such a targeted approach delivered through existing services could be a viable screening strategy for NZ
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]

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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
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