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Trial registered on ANZCTR
Registration number
ACTRN12611000566932
Ethics application status
Approved
Date submitted
30/03/2011
Date registered
2/06/2011
Date last updated
20/07/2011
Type of registration
Retrospectively registered
Titles & IDs
Public title
Validation of the Perth Chest Pain Rule
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Scientific title
Validation of protocols for safe early discharge of patients presenting to Emergency Departments with chest pain
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Secondary ID [1]
259880
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nil
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Universal Trial Number (UTN)
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Trial acronym
MiMiC-2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chest Pain
265471
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Suspected Acute Coronary Syndrome
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Condition category
Condition code
Cardiovascular
265626
265626
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0
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Coronary heart disease
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Public Health
265636
265636
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0
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Health service research
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
An additional 10ml of blood will be drawn with the initial blood taken for standard clinical management. An extra venepuncture of 10ml of blood will be drawn at two hours post presentation to the Emergency Department (ED). At some sites, an additional 5ml of blood will be drawn from the sample taken for standard management at 8-12 hour post presentation.
Data will be collected using a standardised data collection form. Patients will be managed and discharged as determined by their treating clinician as per their clinical judgement - trial blood sample will not be available to clinicians.
Patients will be recuited for six months with the aim for at least 600 patients.
Patients wil be telephoned by research nurses at approximately 30 days post ED discharge and asked a series of standard questions regarding their health and investigations since ED discharge. Hospital discharge summaries and results of investigations will be obtained by research staff.
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Intervention code [1]
264303
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Not applicable
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Comparator / control treatment
Standard Clinical Management of Chest Pain including serial troponin measurement
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Control group
Active
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Outcomes
Primary outcome [1]
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Acute Myocardial Infarction. Final outcome adjudication will be made by two Emergency Physician Investigators or one Emergency Physician and one Cardiologist. When agreement cannot be reached a second Cardiologist or Emergency Physician will be consulted. All clinical, ECG and laboratory data will be made available (except for investigation blood tests).
The definition of Acute Myocardial Infarction will be that of the European Society of Cardiology/American Heart association and is:
1. Rise and/or fall >20% of standard laboratory troponin (I or T) with at least at least one value exceeding the 99th percentile of the distribution in healthy population or the lowest level for which a 10% coefficient of variation can be demonstrated, across at least two blood draws over at least 6 hours, together with at least one of the following
a. Symptoms consistent with ACS
b. ECG changes indicative of new ischaemia (new ST-T changes or new LBBB)
c. Development of pathological Q waves on ECG
d. Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality
OR
2. Sudden, unexpected cardiac death, with cardiac arrest, associated with symptoms of myocardial ischaemia and presumed new ST-elevation or LBBB, or evidence of coronary thrombosis at angiography or autopsy, but death occurring before biomarker samples could be obtained, or before their likely appearance in the blood.
OR
3. Pathological findings of AMI at autopsy
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Assessment method [1]
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Timepoint [1]
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within 30 days of Emergency Department attendance
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Primary outcome [2]
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All cause mortality. Death will be determined from hospital records or the hospital morbidity system which is regularly updated from the WA Births and Deaths Registry
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Assessment method [2]
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Timepoint [2]
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within 30 days of Emergency Department attendance
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Primary outcome [3]
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Emergency or urgent coronary revascularisation. Coronary revascularisation is a hard end point. Determination of emergency/urgent will be made by the treating cardiologist.
AHA/ESC definitions will again be used and are:
Emergency procedure required as emergency because of clinical instability ? eg cardiogenic shock, pulmonary oedema, ischaemic dysfunction, unresolved symptoms despite maximal non-invasive therapy, or evolving myocardial infarction
Urgent Not emergency, not elective, and performed during present admission to minimise risk of deterioration
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Assessment method [3]
262427
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Timepoint [3]
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within 30 days of Emergency Department attendance
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Secondary outcome [1]
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Significant non-cardiac diagnoses such as Pulmonary Embolism and aortic dissection, and the time point at which the alternate diagnosis was determined.
Diagnoses will be determined from hospital records including discharge summaries and investigation results. Where appropriate, discussions will be held with the treating clinician.
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Assessment method [1]
273730
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Timepoint [1]
273730
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within 30 days of Emergency Department attendance
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Eligibility
Key inclusion criteria
Patients attending Emergency Departments with chest pain undergoing serial troponin measurement for exclusion of acute coronary syndrome
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
single troponin measurement, unable to consent, unlikely to be able to obtain follow-up (eg. overseas visitors), pregnant
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Study design
Purpose
Screening
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Duration
Cross-sectional
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Selection
Convenience sample
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
14/02/2011
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
600
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Department of Health, WA
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Address [1]
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189 Royal Street
Perth WA 6004
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Country [1]
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Australia
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Primary sponsor type
Individual
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Name
Yusuf Nagree
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Address
Fremantle Hospital Emergency Medicine Research Unit
PO Box 480
Fremantle WA 6959
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Country
Australia
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Secondary sponsor category [1]
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Individual
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Name [1]
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Stephen Macdonald
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Address [1]
263882
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Armadale Health Service
PO Box 460
Armadale WA 6992
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Country [1]
263882
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
266743
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South Metropolitan Area Health Service HREC
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Ethics committee address [1]
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c/- Fremantle Hospital PO Box 480 Fremantle WA 6959
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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01/09/2010
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Approval date [1]
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13/10/2010
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Ethics approval number [1]
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1/10/0375
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Summary
Brief summary
Chest pain is a common reason for presentation to an Emergency Department. Current management usually involves observing patients in an Emergency Department over 8-12 hours doing repeated heart tracings and blood tests. A large trial in Perth and overseas studies have suggested that it is possible to shorten this observation period to 2 hours using a panel of blood tests and looking at particular patient characteristics. The aim of this study is to ensure that changing to this method of management will not cause an increase in adverse patient outcomes
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Trial website
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Trial related presentations / publications
the results of the cohort trial (MIMIC study) are currently being written up for publication
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Yusuf Nagree
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Address
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Fremantle Hospital Emergency Medicine Research Unit
Fremantle Hospital
PO Box 480
Fremantle WA 6959
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Country
15638
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Australia
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Phone
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+61 8 9431 3733
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Fax
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+61 8 9431 3711
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Email
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[email protected]
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Contact person for scientific queries
Name
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Yusuf Nagree
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Address
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Fremantle Hospital Emergency Medicine Research Unit
Fremantle Hospital
PO Box 480
Fremantle WA 6959
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Country
6566
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Australia
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Phone
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+61 8 9431 3733
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Fax
6566
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Email
6566
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[email protected]
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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
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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