Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000039280
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 of the structure of a newly identified hormone in the blood to help diagnose the cause of chest pain.
Scientific title
A study to determine the amino acid structure of plasma B-type Natriuretic Peptide signal peptide (BNP-SP) as a specific and early clinical biomarker of acute myocardial infarction in patients with chest pain.
Universal Trial Number (UTN)
Trial acronym
BNP Signal Peptide Stucture Study "SSS"
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute myocardial infarction 3792 0
Condition category
Condition code
Cardiovascular 3969 3969 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Using specific immunoassay, peptide sequencing, mass spectrometry, high performance liquid chromatography (HPLC), we will determine the amino acid structure of plasma B-type Natriuretic Peptide signal peptide (BNP-SP). A single 50ml blood sample will be collected at admission from people who present to hospital within 8 hours of onset of symptoms with evidence of an acute myocardial infarction. This study is limited to the collection of a single blood sample only and will continue until 70 samples of 50 mls each have been collected.
Intervention code [1] 3510 0
Early detection / Screening
Comparator / control treatment
uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4873 0
The primary outcome of this study will be the identification on brain natriuretic peptide signal peptide (BNP-SP) amino acid structure. Using specific immunoassay, peptide sequencing, mass spectrometry, high performance liquid chromatography (HPLC), we will determine the amino acid structure of plasma B-type Natriuretic Peptide signal peptide (BNP-SP).
Timepoint [1] 4873 0
One blood sample of 50mls taken within 8 hours of onset of symptoms of a heart attack
Secondary outcome [1] 8221 0
n/a
Timepoint [1] 8221 0
n/a

Eligibility
Key inclusion criteria
70 patients presenting to the Accident & Emergency department or the Coronary Care Unit of Christchurch Hospital with typical chest pains (<8 hours from onset), clear evidence of "ST" segment elevation on Electrocardioegraph (ECG) together with a rise of plasma Troponin levels
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to give informed consent Unable to comply with study requirements

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/01/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment outside Australia
Country [1] 1247 0
New Zealand
State/province [1] 1247 0

Funding & Sponsors
Funding source category [1] 3976 0
Government body
Name [1] 3976 0
Health Research Council of New Zealand
Country [1] 3976 0
New Zealand
Primary sponsor type
Government body
Name
Health Research Council of New Zealand
Address
PO Box 5541, Wellesley Street, Auckland, 1141, New Zealand
Country
New Zealand
Secondary sponsor category [1] 3565 0
None
Name [1] 3565 0
Address [1] 3565 0
Country [1] 3565 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6125 0
Upper South B Regional Ethics Committee
Ethics committee address [1] 6125 0
Ministry of Health
PO Box 3877
Christchurch 8140
Ethics committee country [1] 6125 0
New Zealand
Date submitted for ethics approval [1] 6125 0
Approval date [1] 6125 0
15/01/2007
Ethics approval number [1] 6125 0

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 shown that it has potential to specifically and rapidly identify cardiac ischemia. Using specific immunoassay, peptide sequencing, mass spectrometry, high performance liquid chromatography (HPLC), we will determine the amino acid structure of BNP-SP. In order to complete this detailed analysis, we need approximately 3.5L of blood from patients who have recently suffered an acute myocardial infarction to provide sufficient BNP-SP We therefore require a single venous blood sample of 50 mls each from 70 people taken within 8 hours of onset of symptoms of heart attack. This sample can be taken in conjunction with routine blood tests upon admission to hospital.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29006 0
Address 29006 0
Country 29006 0
Phone 29006 0
Fax 29006 0
Email 29006 0
Contact person for public queries
Name 12163 0
Lorraine Skelton
Address 12163 0
Department of Medicine
University of Otago
Christchurch School of Medicine and Health Sciences
PO Box 4345
Christchurch 8140
Country 12163 0
New Zealand
Phone 12163 0
+643 364 1063
Fax 12163 0
+643 364 1115
Email 12163 0
[email protected]
Contact person for scientific queries
Name 3091 0
Dr Chris Pemberton
Address 3091 0
Department of Medicine
University of Otago
Christchurch School of Medicine and Health Sciences
PO Box 4345
Christchurch 8140
Country 3091 0
New Zealand
Phone 3091 0
+643 364 0887
Fax 3091 0
+943 364 0818
Email 3091 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

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