Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000396022
Ethics application status
Approved
Date submitted
13/04/2010
Date registered
18/05/2010
Date last updated
18/05/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Study of ability of plasma Pre-pro Brain natriuretic peptide (NP) Signal Peptide to detect Inducible Cardiac Ischemia
Scientific title
The Study of ability of plasma Pre-pro Brain natriuretic peptide Signal Peptide (BNP-SP)to detect Inducible Cardiac Ischemia in those with intermediate to high risk.
Secondary ID [1] 251779 0
None
Universal Trial Number (UTN)
Trial acronym
Signal Peptide and Inducible Cardiac Ischaemia : SP-ICI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiac ischaemia 257143 0
Condition category
Condition code
Cardiovascular 257300 257300 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
Serial sampling of plasma Pre-pro Brain natriuretic peptide Signal Peptide (BNP-SP)patients recruited over 1 year with controlled induced cardiac ischemia in the form of either dobutamine stress testing or treadmill exercise tolerance testing is proposed.
The dobutamine stress echocardiograph test takes about 1 hour and involves an injection of 10-40mcg/kg/min of dobutamine to stimulate the heart in a similar way to exercise while measuring the effect using ultrasound.
The Treadmill exercise tolerance test takes about 30 minutes in total and involves an electrocardiogragh recording while walking on a treadmill.
Venous blood samples will be drawn at baseline (0), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, and 4 hours. Later sampling (=1wk) will not be carried out. For each blood sample, we will measure plasma BNP-SNP, troponin and N-terminal Brain natriuretic peptide (NT-proBNP). Other signal peptides will be looked at namely ghrelin SP. Depending on results this biomarker has the potential to improve the sensitivity of stress testing. In addition, this study may provide insights into the mechanisms of release of this novel group of peptides.
Intervention code [1] 256298 0
Not applicable
Comparator / control treatment
Protocol 1: Treadmill exercise Test:
- 16 patients with intermediate to high pretest probability of cardiac chest pain.
- 5 individuals with low pretest probability of cardiac pathology

Protocol 2: Dobutamine Stress Echocardiography:
- 16 patients with intermediate to high pretest probability of cardiac chest pain.
- 5 individuals with low pretest probability of cardiac pathology
Control group
Active

Outcomes
Primary outcome [1] 258207 0
To determine whether serial measurements of BNP-SP measured via venous blood sampling will be able to detect inducible cardiac ischemia. The temporal pattern of release of BNP SP during 1) treadmill exercise tolerance testing and 2) dobutamine stress echocardiography will be determined in those with intermediate to high risk cardiac chest pain and compared to the pattern of release of patients with low risk of cardiac pathology
Timepoint [1] 258207 0
at baseline (0), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, and 4 hours for both treadmill and dobutamine stress tests
Secondary outcome [1] 263857 0
The pattern of release will also be compared and contrasted to N-terminal Brain natriuretic peptide (NT-BNP) and high sensitivity troponin in venous blood sampling
Timepoint [1] 263857 0
at baseline (0), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, and 4 hours for both treadmill and dobutamine stress tests

Eligibility
Key inclusion criteria
Protocol 1)
Inclusion criteria:
Intermediate to high pretest probability of cardiac ischemia as judged by cardiac risk factors, nature of chest pain and past cardiac history.
5 healthy volunteers with no history of cardiovascular or other significant illness will enrolled as a control group.
Protocol 2)
Inclusion criteria:
Intermediate to high pretest probability of cardiac ischemia as judged by cardiac risk factors, nature of chest pain and past cardiac history.
5 healthy volunteers with no history of cardiovascular or other significant illness will enrolled as a control group.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Protocol 1:
Exclusion Criteria:
Patients with atrial fibrillation, pacemakers, significant valvular disease, aged over 70, recent infarction will be excluded.
Patients in whom resting electrocardiograms (ECGs) show abnormalities that preclude interpretation of exercise-induced changes for example left bundle branch block, left ventricular hypertrophy, 1 mm ST segment changes or pre-excitation will be excluded.
Patients with poor echo windows will be excluded.
Anemia as defined as a hemoglobin level less than 100
Unable to give informed consent
Unable to comply with study requirements
Protocol 2:
Exclusion criteria:
Poor echocardiographic windows.
Chronic atrial fibrillation.
Age less than 18 or greater than 80.
Anemia as defined as a hemoglobin level less than 100
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
25/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment outside Australia
Country [1] 2583 0
New Zealand
State/province [1] 2583 0

Funding & Sponsors
Funding source category [1] 256798 0
Charities/Societies/Foundations
Name [1] 256798 0
Christchurch Cardioendocrine Research Trust
Country [1] 256798 0
New Zealand
Primary sponsor type
Other
Name
Christchurch Cardioendocrine Research Trust
Address
Department of Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 256074 0
None
Name [1] 256074 0
Address [1] 256074 0
Country [1] 256074 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258821 0
Upper South B Regional Ethics Committee
Ethics committee address [1] 258821 0
Ministry of Health
PO Box 3877
Christchurch 8140
Ethics committee country [1] 258821 0
New Zealand
Date submitted for ethics approval [1] 258821 0
Approval date [1] 258821 0
23/03/2010
Ethics approval number [1] 258821 0

Summary
Brief summary
This is a prospective observational pilot study of the diagnostic utility of a novel biomarker B-type natriuretic peptide signal peptide (BNP-SP)in the assessment of inducible cardiac ischemia. Previously performed studies have demonstrated a clear, consistent and early peak of BNP-SP in the setting of indisputable cardiac ischemia and necrosis in patients presenting with ST elevation myocardial infarction. The patterns of release in the setting of less extreme forms of cardiac ischemia have not been previously defined.
Serial sampling of BNP-SP in patients with controlled induced cardiac ischemia in the form of dobutamine stress testing and treadmill exercise tolerance testing is proposed.
Venous blood samples will be drawn at baseline (0), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, and 4 hours. Later sampling (=1wk) will not be carried out. For each blood sample, we will measure plasma BNP-SNP, troponin and NT-proBNP. Other signal peptides will be looked at namely ghrelin SP. Depending on results this biomarker has the potential to improve the sensitivity of stress testing. In addition, this study may provide insights into the mechanisms of release of this novel group of peptides.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31042 0
Address 31042 0
Country 31042 0
Phone 31042 0
Fax 31042 0
Email 31042 0
Contact person for public queries
Name 14289 0
Dr Maithri Siriwardena
Address 14289 0
Department of Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country 14289 0
New Zealand
Phone 14289 0
+643 364 0640
Fax 14289 0
Email 14289 0
[email protected]
Contact person for scientific queries
Name 5217 0
Dr Maithri Siriwardena
Address 5217 0
Department of Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country 5217 0
New Zealand
Phone 5217 0
+643 364 0640
Fax 5217 0
Email 5217 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
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Documents added automatically
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