Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000136505
Ethics application status
Approved
Date submitted
19/04/2006
Date registered
20/04/2006
Date last updated
20/04/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Vasoactive peptides: regional plasma concentrations and correlation with cardiac haemodynamic status.
Scientific title
An observational study of the regional concentrations of vasoactive neurohormones in patients with cardiovascular disease, and their assocation with concurrent haemodynamic status.
Universal Trial Number (UTN)
Trial acronym
GRADIENT study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 1104 0
Condition category
Condition code
Cardiovascular 1184 1184 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a cross-sectional and observational study. Regional transorgan arterial and venous blood sampling during diagnostic and interventional coronary angiography will be performed. Plasma will be assayed for neurohormones. Results will be correlated with invasive haemodynamic measures taken at the time of the angiogram.
Intervention code [1] 988 0
None
Comparator / control treatment
No comparator.
Control group

Outcomes
Primary outcome [1] 1596 0
To document the regional plasma concentrations of vasoactive peptides (including natriuretic peptides, angiotensin II, aldosterone and urocortin 1) in individuals with a spectrum of cardiovascular disease at a single time point.
Timepoint [1] 1596 0
Secondary outcome [1] 2893 0
To document the transcardiac gradient of vasoactive neurohormones across a spectrum of cardiac and renal function at a single time point.
Timepoint [1] 2893 0

Eligibility
Key inclusion criteria
1) Individuals requiring diagnostic or interventional coronary angiogram.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
:1) Clinical contraindication to invasive coronary angiographic or percutaneous procedures2) Hypotension (systolic blood pressure<100mmHg)3) Anuria4) Requirement for emergency percutaneous intervention where obtaining research samples might delay treatment.

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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/03/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 302 0
New Zealand
State/province [1] 302 0

Funding & Sponsors
Funding source category [1] 1294 0
University
Name [1] 1294 0
Christchurch Cardioendocrine Research Group
Country [1] 1294 0
New Zealand
Funding source category [2] 1295 0
Government body
Name [2] 1295 0
Health Research Council of New Zealand
Country [2] 1295 0
New Zealand
Primary sponsor type
Individual
Name
Professor Mark Richards, Professor in Medicine, Christchurch School of Medicine and Health Sciences
Address
Country
New Zealand
Secondary sponsor category [1] 1144 0
University
Name [1] 1144 0
Christchurch School of Medicine and Health Sciences
Address [1] 1144 0
Country [1] 1144 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2624 0
Chirstchurch School of Medicine and Health Scieinces
Ethics committee address [1] 2624 0
Ethics committee country [1] 2624 0
New Zealand
Date submitted for ethics approval [1] 2624 0
Approval date [1] 2624 0
Ethics approval number [1] 2624 0
Ethics committee name [2] 2625 0
New Zealand Upper South B Regional Ethics Committee
Ethics committee address [2] 2625 0
Ethics committee country [2] 2625 0
New Zealand
Date submitted for ethics approval [2] 2625 0
Approval date [2] 2625 0
Ethics approval number [2] 2625 0
URB/06/02/010

Summary
Brief summary
In 100 individuals with known or suspected heart disease we propose to describe the trans-cardiac (ie difference between circulation supplying heart and draining heart) and trans-organ (ie across the circulation of an organ) gradients of an array of circulating proteins of known and potential significance in heart disease. The study will determine whether these proteins are formed or eliminated by each organ studied and extend the knowledge of the metabolism of these proteins within the body.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36350 0
Address 36350 0
Country 36350 0
Phone 36350 0
Fax 36350 0
Email 36350 0
Contact person for public queries
Name 10177 0
Dr Suetonia Palmer
Address 10177 0
Department of Medicine
Christhcurch School of Medicine and Health Sciences
PO Box 4345
Christchurch 8001
Country 10177 0
New Zealand
Phone 10177 0
+64 3 3640496
Fax 10177 0
+64 3 3641115
Email 10177 0
[email protected]
Contact person for scientific queries
Name 1105 0
Dr Suetonia Palmer
Address 1105 0
Department of Medicine
Christchurch School of Medicine and Health Sciences
PO Box 4345
Christchurch
Country 1105 0
New Zealand
Phone 1105 0
+64 3 3641116
Fax 1105 0
+64 3 3641115
Email 1105 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
SourceTitleYear of PublicationDOI
EmbaseRegional Handling and Prognostic Performance of Circulating Insulin-Like Growth Factor Binding Protein-7 in Heart Failure.2023https://dx.doi.org/10.1016/j.jchf.2023.01.016
Dimensions AIUrotensin II Immunoreactivity in the Human Circulation: Evidence for Widespread Tissue Release2009https://doi.org/10.1373/clinchem.2009.131748
Dimensions AIB-Type Natriuretic Peptide Forms within the Heart, Coronary Sinus, and Peripheral Circulation in Humans: Evidence for Degradation before Secretion2014https://doi.org/10.1373/clinchem.2013.210435
N.B. These documents automatically identified may not have been verified by the study sponsor.