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Trial registered on ANZCTR
Registration number
ACTRN12609000040268
Ethics application status
Approved
Date submitted
6/10/2008
Date registered
19/01/2009
Date last updated
19/01/2009
Type of registration
Retrospectively registered
Titles & IDs
Public title
A study to determine the ability of plasma B-type Natriuretic Peptide signal peptide (BNP-SP) concentrations to act as a specific and early clinical biomarker of Acute Myocardial Infarction
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Scientific title
A study to determine the ability of plasma B-type Natriuretic Peptide signal peptide (BNP-SP) concentrations to act as a specific and early clinical biomarker of Acute Myocardial Infarction in patients with chest pain.
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Universal Trial Number (UTN)
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Trial acronym
BNP Signal Peptide measurement in Acute Myocardial Infaction “SP-AMI”
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
acute myocardial infarction
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Condition category
Condition code
Cardiovascular
4043
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0
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Coronary heart disease
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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
We will measure serial BNP-SP concentrations in patients admitted to hospital within 4 hours of symptom onset and with clear documented myocardial infarction to determine if temporal plasma concentrations of BNP-Signal Peptide (BNP-SP) achieve peak values within 1-3 hours of onset of infarction. Blood samples will be collected at 0, 0.5, 1. 2. 4, 8, 12, 24, 48 and 72 hours post admission.
The study will continue until recruitment and blood sampling is complete for 50 people with acute myocardial infarction, 10 with chronic renal failure on maintenance haemodialysis, 5 patients with hypothyroidism, 5 patients with thyrotoxicosis and 10 patients presenting to the emergency department with acute heart failure not secondary to Acute Myocardial Infarction.
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Intervention code [1]
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Early detection / Screening
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Comparator / control treatment
uncontrolled
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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The primary outcome of this proposal will be the identification of B-type Natriuretic Peptide signal peptide (BNP-SP) as a novel, specific biomarker of acute cardiac injury. For each blood sample, we will measure plasma BNP-SP as well as the standard serial biomarker concentrations of troponin, creatine kinase and myoglobin.
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Assessment method [1]
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Timepoint [1]
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Blood samples will be takn on admission, then at 0.5, 1, 2, 4, 8, 12, 24, 48 and 72 hours, pre-discharge and 1 month post discharge
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Secondary outcome [1]
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The secondary outcome will be the potential identification of a new class of circulating biomarkers that may have diagnostic potential in pathophysiology. For each blood sample, we will measure plasma BNP-SP as well as the standard serial biomarker concentrations of troponin, creatine kinase and myoglobin.
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Assessment method [1]
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Timepoint [1]
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Blood samples will be takn on admission, then at 0.5, 1, 2, 4, 8, 12, 24, 48 and 72 hours, pre-discharge and 1 month post discharge
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Eligibility
Key inclusion criteria
50 males or females
18 years of age or older
Admitted to the coronary care unit of Christchurch Hospital with typical chest pains (<4 hours from onset), clear evidence of "ST" segment elevation on Electrocardiograph together with a rise and fall of plasma Troponin levels
and
10 patients with chronic renal failure on maintenance haemodialysis
5 patients with hypothyroidism and 5 patients with thyrotoxicosis
10 patients presenting to the emergency department with acute heart failure not secondary to Acute Myocardial Infarction
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Minimum age
18
Years
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Maximum age
No limit
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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
Unable to give informed consent
Unable to comply with study requirements
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Study design
Purpose
Screening
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Duration
Cross-sectional
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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
Completed
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Date of first participant enrolment
Anticipated
22/07/2007
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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
80
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Health Research Council of New Zealand
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Address [1]
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PO Box 5541, Auckland, 1141
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Country [1]
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New Zealand
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Funding source category [2]
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Government body
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Name [2]
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Health Research Council of New Zealand
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Address [2]
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PO Box 5541, Auckland, 1141
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Country [2]
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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
PO Box 5541, Auckland, 1141
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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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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Upper South A Regional Ethics Committee
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Ethics committee address [1]
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Ministry of Health
PO Box 3877
Christchurch 8140
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
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Approval date [1]
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14/03/2007
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Ethics approval number [1]
6052
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Summary
Brief summary
Early clinical detection of acute coronary syndromes (ACS) can be difficult. In particular, distinction between cardiac and non-cardiac events may entail 12-36 hours of delay whilst serial biomarker results are awaited and/or subsequent tests (such as exercise electrocardiography) are performed. We have achieved the first ever identification of a signal peptide in the circulation (B-type Natriuretic Peptide signal peptide (BNP-SP)) and show that it has potential to specifically and rapidly identify cardiac ischemia.
We will measure serial BNP-SP concentrations in patients with clear documented myocardial infarction. This research has the potential to speed up diagnosis and ultimately improve outcomes for patients with acute coronary events.
50 patients presenting to the coronary care unit of Christchurch Hospital with typical chest pains (=4 hours from onset), clear evidence of ST-elevation on ECG together with a rise and fall of plasma troponin levels will be studied. Venous blood samples will be drawn at baseline (0), 0.5, 1, 2, 4, 8, 12, 24, 48 and 72 hours.
For each blood sample, we will also measure standard plasma biomarkers of myocardial injury.
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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
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Lorraine Skelton
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Address
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Department of Medicine
University of Otago
Christchurch School of Medicine & Health Sciences
PO Box 4345
Christchurch 8140
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Country
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New Zealand
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Phone
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+643 364 1063
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Fax
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+643 364 1115
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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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Dr Chris Pemberton
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Address
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Department of Medicine
University of Otago
Christchurch School of Medicine & Health Sciences
PO Box 4345
Christchurch 8140
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Country
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New Zealand
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Phone
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+643 364 0887
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Fax
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+643 364 0818
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Email
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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
Source
Title
Year of Publication
DOI
Dimensions AI
B-Type Natriuretic Peptide Signal Peptide Circulates in Human Blood
2010
https://doi.org/10.1161/circulationaha.109.909937
Dimensions AI
First Identification of Circulating Prepro–A-Type Natriuretic Peptide (PreproANP) Signal Peptide Fragments in Humans: Initial Assessment as Cardiovascular Biomarkers
2012
https://doi.org/10.1373/clinchem.2011.176990
N.B. These documents automatically identified may not have been verified by the study sponsor.
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