Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000212550
Ethics application status
Approved
Date submitted
29/05/2006
Date registered
30/05/2006
Date last updated
22/01/2020
Date data sharing statement initially provided
22/01/2020
Date results information initially provided
22/01/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
The PMI Study
Scientific title
A cohort observational study to assay natriuretic peptide levels in people who have had a Myocardial Infarction (MI) to determine if they are better prognostic indicators of death and all cardiovascular events after acute MI than other indices as well as a better reflection of the left ventricular function as assessed by Radionuclide Ventriculography
Secondary ID [1] 291045 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myocardial infarction 1190 0
Condition category
Condition code
Cardiovascular 1275 1275 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
natriuretic peptide levels 24-96 hours post myocardial infarction and at 3-5 months and 12 months post discharge
Intervention code [1] 1076 0
None
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1723 0
Natriuretic peptide levels are better prognostic indicators of death and all cardiovascular events after acute myocardial infarction than other indices
Timepoint [1] 1723 0
24 - 96 hours post MI and at 3 - 5 months and 12 months post discharge
Secondary outcome [1] 3075 0
Natriuretic peptide levels better reflect left ventricular function.
Timepoint [1] 3075 0
Assessed by radionuclide ventriculography and/or echocardiography24-96 hours post myocardial infarction and at 3-5 months and 12 months post discharge.

Eligibility
Key inclusion criteria
Diagnosis of MI24-96h from symptoms onsetMale or female18-80 years of ageCK =400u/L.andchest pain or other symptoms suggesting myocardial ischaemiaorST elevation of = 1mm in 2 contigous ECG leadsor New pathological Q waves.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to provide informed consent.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/11/1994
Actual
13/11/1994
Date of last participant enrolment
Anticipated
Actual
10/06/2001
Date of last data collection
Anticipated
31/12/2024
Actual
31/12/2018
Sample size
Target
1000
Accrual to date
Final
1000
Recruitment outside Australia
Country [1] 322 0
New Zealand
State/province [1] 322 0
Christchurch

Funding & Sponsors
Funding source category [1] 1395 0
Government body
Name [1] 1395 0
Health Research Council of New Zealand
Country [1] 1395 0
New Zealand
Primary sponsor type
Government body
Name
Health Research Council of New Zealand
Address
Country
New Zealand
Secondary sponsor category [1] 1227 0
Charities/Societies/Foundations
Name [1] 1227 0
National Heart Foundation of New Zealand
Address [1] 1227 0
Country [1] 1227 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2747 0
Christchurch
Ethics committee address [1] 2747 0
Ethics committee country [1] 2747 0
New Zealand
Date submitted for ethics approval [1] 2747 0
Approval date [1] 2747 0
30/09/1994
Ethics approval number [1] 2747 0
97/784

Summary
Brief summary
This is an cohort observational study to assess whether natriuretic peptide levels are better prognostic indicators of death and all cardiovascular events after acute myocardial infarction than other indices, and also better reflect left ventricular function as assessed by radionuclide ventriculography and/or echocardiography.
Measurements will be carried out,
within 24-96 hours of onset of chest pain and again at 3-5 months and 12 months after acute infarction.
Clinical History will be recorded for 5 years
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36057 0
Prof Mark Richards
Address 36057 0
Department of Medicine. University of Otago, Christchurch. PO Box 4345 Christchurch. 8140. New Zealand
Country 36057 0
New Zealand
Phone 36057 0
+6433641063
Fax 36057 0
+6433641115
Email 36057 0
[email protected]
Contact person for public queries
Name 10265 0
Ms Lorraine Skelton
Address 10265 0
Department of Medicine
Christchurch School of Medicine and Health Sciences
PO Box 4345
Christchurch
Country 10265 0
New Zealand
Phone 10265 0
+64 3 3641063
Fax 10265 0
+64 3 3641115
Email 10265 0
[email protected]
Contact person for scientific queries
Name 1193 0
Prof Professor Mark Richards
Address 1193 0
Department of Medicine
Christchurch School of Medicine and Health Sciences
PO Box 4345
Christchurch
Country 1193 0
New Zealand
Phone 1193 0
+64 3 3641116
Fax 1193 0
+64 3 3641115
Email 1193 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes B-Type Natriuretic Peptides and Ejection Fraction ... [More Details]

Documents added automatically
No additional documents have been identified.