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DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
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Trial registered on ANZCTR
Registration number
ACTRN12605000448640
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
21/09/2005
Date last updated
21/09/2005
Type of registration
Retrospectively registered
Titles & IDs
Public title
Healthy Volunteers for Heart Disease Research
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Scientific title
Christchurch Healthy Volunteers for The Study of Heart Disease
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers
563
0
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Condition category
Condition code
Cardiovascular
638
638
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0
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Normal development and function of the cardiovascular system
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
None
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Intervention code [1]
574
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None
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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To establish a resource of DNA samples from healthy volunteers for the study of genetic variants associated with increased risk of cardiovascular disease.
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Assessment method [1]
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Timepoint [1]
749
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Secondary outcome [1]
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The blood samples will be used as a source of DNA and a plasma sample from each individual will be stored indefinitely to allow subsequent measurement of relevant circulating and tissue factors (eg. lipid profiles and cardiovascular hormones including natriuretic peptide hormones, angiotensin II, renin and their receptors etc).
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Assessment method [1]
1533
0
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Timepoint [1]
1533
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Eligibility
Key inclusion criteria
Potential participants will be selected at random from the electoral rolls covering the greater Christchurch area, including the Maori electorate of Te Tai Tonga.Individuals will be approached by mail initially with a letter and information sheet briefly explaining the study, inviting them to participate and asking them to supply information about their medical history.
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Minimum age
Not stated
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Maximum age
Not stated
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion of those that have a history of cardiovascular disease.
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/08/2001
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
1500
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
221
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New Zealand
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State/province [1]
221
0
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Funding & Sponsors
Funding source category [1]
699
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Government body
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Name [1]
699
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Health Research Council of New Zealand
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Address [1]
699
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Country [1]
699
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New Zealand
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Primary sponsor type
Government body
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Name
Health Research Council of New Zealand
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Address
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
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n/a
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Address [1]
584
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Country [1]
584
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
1903
0
Christchurch
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Ethics committee address [1]
1903
0
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Ethics committee country [1]
1903
0
New Zealand
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Date submitted for ethics approval [1]
1903
0
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Approval date [1]
1903
0
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Ethics approval number [1]
1903
0
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Summary
Brief summary
Heart disease results from the interaction of the genes we inherit and lifestyle factors, such as diet and smoking. To understand the role that genes play in the development of heart disease within the local population, the objective of the project is to collect blood samples from 1500 normal healthy individuals aged from 30 to 82 selected from the Canterbury region, as a control group for our studies of heart disease. The age and gender profiles of the control group will be matched to those of patients who have had a heart attack or heart failure . The blood samples will be used as a source of DNA (genetic material) to allow determination of individual genetic profiles and associated levels of hormones and lipids in the circulation. The frequencies of gene variants thought to be involved in heart disease in the heart-disease patient groups will be compared with the control group to detect those genes which might contribute to an increased risk of to heart disease within the Canterbury population
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
36230
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Address
36230
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Country
36230
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Phone
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Fax
36230
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Email
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Contact person for public queries
Name
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Professor Mark Richards
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Address
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Christchurch Cardioendocrine Research Group
Department of Medicine
Christchurch School of Medicine and Health Sciences
PO Box 4345
Christchurch 8015
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Country
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New Zealand
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Phone
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+64 3 3640640
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Fax
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+64 3 3641115
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Email
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[email protected]
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Contact person for scientific queries
Name
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Lorraine Skelton
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Address
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Christchurch Cardioendocrine Research Group
Department of Medicine
Christchurch School of Medicine and Health Sciences
PO Box 4345
Christchurch 8015
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Country
691
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New Zealand
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Phone
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+64 3 3641063
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Fax
691
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+64 3 3641115
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Email
691
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[email protected]
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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.
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