Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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 information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000448640
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
21/09/2005
Date last updated
26/08/2024
Date data sharing statement initially provided
26/08/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Healthy Volunteers for Heart Disease Research
Scientific title
Christchurch Healthy Volunteers for The Study of Heart Disease
Secondary ID [1] 312818 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
heart disease 563 0
Condition category
Condition code
Cardiovascular 638 638 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
10
Target follow-up type
Years
Description of intervention(s) / exposure
We will collect urine and blood samples for plasma and DNA/RNA from 6000 normal healthy individuals aged from 18-100 selected from the Canterbury region, for use as a control group for genetic association studies of cardiovascular and associated metabolic disease (eg diabetes). The age and gender profiles of the control group will be matched to those of the patients in the Christchurch Heart Institute observational and interventional studies of hypertension and heart disease.
Intervention code [1] 329357 0
Not applicable
Comparator / control treatment
not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 749 0
To establish a resource of DNA samples from healthy volunteers for the study of genetic variants associated with increased risk of cardiovascular disease.
Timepoint [1] 749 0
at baseline visit
Secondary outcome [1] 1533 0
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).
Timepoint [1] 1533 0
not applicable

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.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion of those that have a history of cardiovascular disease.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2001
Actual
7/01/2002
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/12/2030
Actual
Sample size
Target
6000
Accrual to date
3400
Final
Recruitment outside Australia
Country [1] 221 0
New Zealand
State/province [1] 221 0
Canterbury

Funding & Sponsors
Funding source category [1] 699 0
Government body
Name [1] 699 0
Health Research Council of New Zealand
Country [1] 699 0
New Zealand
Primary sponsor type
University
Name
Health Research Council of New Zealand
Address
Country
New Zealand
Secondary sponsor category [1] 584 0
None
Name [1] 584 0
n/a
Address [1] 584 0
Country [1] 584 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1903 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 1903 0
https://ethics.health.govt.nz/about/southern-health-and-disability-ethics-committee/
Ethics committee country [1] 1903 0
New Zealand
Date submitted for ethics approval [1] 1903 0
01/05/2001
Approval date [1] 1903 0
30/05/2001
Ethics approval number [1] 1903 0
CTY/01/05/062

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 6000 normal healthy individuals aged from 18 years 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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36230 0
Prof Mark Richards
Address 36230 0
Department of Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country 36230 0
New Zealand
Phone 36230 0
+643 3640640
Fax 36230 0
+643 3641115
Email 36230 0
[email protected]
Contact person for public queries
Name 9763 0
Professor Mark Richards
Address 9763 0
Christchurch Cardioendocrine Research Group
Department of Medicine
Christchurch School of Medicine and Health Sciences
PO Box 4345
Christchurch 8015
Country 9763 0
New Zealand
Phone 9763 0
+64 3 3640640
Fax 9763 0
+64 3 3641115
Email 9763 0
[email protected]
Contact person for scientific queries
Name 691 0
Lorraine Skelton
Address 691 0
Christchurch Cardioendocrine Research Group
Department of Medicine
Christchurch School of Medicine and Health Sciences
PO Box 4345
Christchurch 8015
Country 691 0
New Zealand
Phone 691 0
+64 3 3641063
Fax 691 0
+64 3 3641115
Email 691 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.