Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000057280
Ethics application status
Approved
Date submitted
16/10/2008
Date registered
23/01/2009
Date last updated
19/12/2022
Date data sharing statement initially provided
14/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study to determine the ability of a blood test for B-type Natriuretic Peptide signal peptide (BNP-SP) to act as an early indicator in Acute Coronary Syndrome (ACS)).
Scientific title
A study to determine the diagnostic test performance (sensitivity, specificity, negative predictive value, positive predictive value, accuracy and prognostic value) of B-type Natriuretic Peptide Single Peptide (BNP-SP) measurement in detection of Acute Coronary Syndrome (ACS) (including those with ischemia short of infarction) within a population of “all-comers” with chest discomfort
Signal Peptide in Acute Coronary Events
Secondary ID [1] 283438 0
Nil
Universal Trial Number (UTN)
Trial acronym
The Signal Peptide in Acute Coronary Events Study: "SP-ACE"
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome 3836 0
Condition category
Condition code
Cardiovascular 4024 4024 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 B-type Natriuretic Peptide signal peptide (BNP-SP)concentrations in 2000 patients presenting to the Emergency Department within 24 hours of symptom onset of possible Acute Coronary Syndrome (ACS).

Clinical history and physical examination will be undertaken. Venous blood samples for cardiac biomarkers will be obtained at 1, 2, 3, hours post admission and again at 6-12, 24 & 48 hours if still in hospital or attend an outpatient clinic.
Patients will be followed up for 30 day and 6 month events for the composite end-point of: All cause mortality and/or new ACS and/or readmission to hospital with arrhythmia or heart failure.
Intervention code [1] 3618 0
Not applicable
Comparator / control treatment
n/a
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4926 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] 4926 0
Additional assessment time points at 3, 6-12 & 48 hours and 30 days and 6 months post admission
Secondary outcome [1] 8309 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] 8309 0
Additional assessment time points at 3, 6-12 & 48 hours and 30 days and 6 months post admission

Eligibility
Key inclusion criteria
Male or female
18 years of age or older
presenting to hospital with possible acute coronary syndrome
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
Recruiting
Date of first participant enrolment
Anticipated
6/11/2007
Actual
16/11/2007
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
2000
Accrual to date
1030
Final
Recruitment outside Australia
Country [1] 1281 0
New Zealand
State/province [1] 1281 0

Funding & Sponsors
Funding source category [1] 4400 0
Government body
Name [1] 4400 0
Health Research Council of New Zealand
Country [1] 4400 0
New Zealand
Primary sponsor type
Government body
Name
Health Research Council of New Zealand
Address
PO Box 5541, Wellesley Street, Auckland, 1141
Country
New Zealand
Secondary sponsor category [1] 314556 0
Charities/Societies/Foundations
Name [1] 314556 0
Christchurch Heart Institute Trust
Address [1] 314556 0
Department of Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch 8014
Country [1] 314556 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6154 0
Upper South B Regional Ethics Committee
Ethics committee address [1] 6154 0
PO Box 3877, Christchurch 8140
Ethics committee country [1] 6154 0
New Zealand
Date submitted for ethics approval [1] 6154 0
23/11/2006
Approval date [1] 6154 0
10/04/2007
Ethics approval number [1] 6154 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 2000 patients presenting to the Emergency Department within 24 hours of symptom onset of possible Acute Coronary Syndrome (ACS).

Clinical history and physical examination will be undertaken according to standard care . Venous blood samples for cardiac biomarkers will be obtained 1, 2, 3, hours post admission and again at 6-12, 24 & 48 hours if still in hospital or attending an outpatient clinic
Patients will be followed up for 30 day and 6 month events for the composite end-point of: All cause mortality and/or new ACS and/or readmission to hospital with arrhythmia or heart failure. This research has the potential to speed up diagnosis and ultimately improve outcomes for patients with ACS.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29043 0
Prof Mark Richards
Address 29043 0
Department of Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
New Zealand
Country 29043 0
New Zealand
Phone 29043 0
+643 364 1063
Fax 29043 0
Email 29043 0
mark.richards@cdhb.health.nz
Contact person for public queries
Name 12200 0
Professor Chris Pemberton
Address 12200 0
Department of Medicine
University of Otago
Christchurch School of Medicine & Health Sciences
PO Box 4345
Christchurch 8140
Country 12200 0
New Zealand
Phone 12200 0
+64 3 3648087
Fax 12200 0
+643 364 1115
Email 12200 0
chris.pemberton@otago.ac.nz
Contact person for scientific queries
Name 3128 0
Professor Mark Richards
Address 3128 0
Department of Medicine
University of Otago
Christchurch School of Medicine & Health Sciences
PO Box 4345
Christchurch 8140
Country 3128 0
New Zealand
Phone 3128 0
+643 364 0640
Fax 3128 0
+643 364 1115
Email 3128 0
mark.richards@cdhb.govt.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
refer to contact person for any enquiries


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.