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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
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.
Universal Trial Number (UTN)
Trial acronym
BNP Signal Peptide measurement in Acute Myocardial Infaction “SP-AMI”
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute myocardial infarction 3794 0
Condition category
Condition code
Cardiovascular 4043 4043 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
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.
Intervention code [1] 3514 0
Early detection / Screening
Comparator / control treatment
uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4875 0
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.
Timepoint [1] 4875 0
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
Secondary outcome [1] 8331 0
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.
Timepoint [1] 8331 0
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

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
Minimum age
18 Years
Maximum age
No limit
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1248 0
New Zealand
State/province [1] 1248 0

Funding & Sponsors
Funding source category [1] 3978 0
Government body
Name [1] 3978 0
Health Research Council of New Zealand
Address [1] 3978 0
PO Box 5541, Auckland, 1141
Country [1] 3978 0
New Zealand
Funding source category [2] 3979 0
Government body
Name [2] 3979 0
Health Research Council of New Zealand
Address [2] 3979 0
PO Box 5541, Auckland, 1141
Country [2] 3979 0
New Zealand
Primary sponsor type
Government body
Name
Health Research Council of New Zealand
Address
PO Box 5541, Auckland, 1141
Country
New Zealand
Secondary sponsor category [1] 3567 0
None
Name [1] 3567 0
Address [1] 3567 0
Country [1] 3567 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6052 0
Upper South A Regional Ethics Committee
Ethics committee address [1] 6052 0
Ministry of Health
PO Box 3877
Christchurch 8140
Ethics committee country [1] 6052 0
New Zealand
Date submitted for ethics approval [1] 6052 0
Approval date [1] 6052 0
14/03/2007
Ethics approval number [1] 6052 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 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29008 0
Address 29008 0
Country 29008 0
Phone 29008 0
Fax 29008 0
Email 29008 0
Contact person for public queries
Name 12165 0
Lorraine Skelton
Address 12165 0
Department of Medicine
University of Otago
Christchurch School of Medicine & Health Sciences
PO Box 4345
Christchurch 8140
Country 12165 0
New Zealand
Phone 12165 0
+643 364 1063
Fax 12165 0
+643 364 1115
Email 12165 0
lorraine.skelton@cdhb.govt.nz
Contact person for scientific queries
Name 3093 0
Dr Chris Pemberton
Address 3093 0
Department of Medicine
University of Otago
Christchurch School of Medicine & Health Sciences
PO Box 4345
Christchurch 8140
Country 3093 0
New Zealand
Phone 3093 0
+643 364 0887
Fax 3093 0
+643 364 0818
Email 3093 0
chris.pemberton@otago.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary