Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Scientific title
Validation of protocols for safe early discharge of patients presenting to Emergency Departments with chest pain
Secondary ID [1] 259880 0
nil
Universal Trial Number (UTN)
Trial acronym
MiMiC-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chest Pain 265471 0
Suspected Acute Coronary Syndrome 265472 0
Condition category
Condition code
Cardiovascular 265626 265626 0 0
Coronary heart disease
Public Health 265636 265636 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 264303 0
Not applicable
Comparator / control treatment
Standard Clinical Management of Chest Pain including serial troponin measurement
Control group
Active

Outcomes
Primary outcome [1] 262411 0
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
Timepoint [1] 262411 0
within 30 days of Emergency Department attendance
Primary outcome [2] 262426 0
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
Timepoint [2] 262426 0
within 30 days of Emergency Department attendance
Primary outcome [3] 262427 0
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
Timepoint [3] 262427 0
within 30 days of Emergency Department attendance
Secondary outcome [1] 273730 0
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.
Timepoint [1] 273730 0
within 30 days of Emergency Department attendance

Eligibility
Key inclusion criteria
Patients attending Emergency Departments with chest pain undergoing serial troponin measurement for exclusion of acute coronary syndrome
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
single troponin measurement, unable to consent, unlikely to be able to obtain follow-up (eg. overseas visitors), pregnant

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/02/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264763 0
Government body
Name [1] 264763 0
Department of Health, WA
Country [1] 264763 0
Australia
Primary sponsor type
Individual
Name
Yusuf Nagree
Address
Fremantle Hospital Emergency Medicine Research Unit
PO Box 480
Fremantle WA 6959
Country
Australia
Secondary sponsor category [1] 263882 0
Individual
Name [1] 263882 0
Stephen Macdonald
Address [1] 263882 0
Armadale Health Service
PO Box 460
Armadale WA 6992
Country [1] 263882 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266743 0
South Metropolitan Area Health Service HREC
Ethics committee address [1] 266743 0
c/- Fremantle Hospital
PO Box 480
Fremantle WA 6959
Ethics committee country [1] 266743 0
Australia
Date submitted for ethics approval [1] 266743 0
01/09/2010
Approval date [1] 266743 0
13/10/2010
Ethics approval number [1] 266743 0
1/10/0375

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
Trial website
Trial related presentations / publications
the results of the cohort trial (MIMIC study) are currently being written up for publication
Public notes

Contacts
Principal investigator
Name 32391 0
Address 32391 0
Country 32391 0
Phone 32391 0
Fax 32391 0
Email 32391 0
Contact person for public queries
Name 15638 0
Yusuf Nagree
Address 15638 0
Fremantle Hospital Emergency Medicine Research Unit
Fremantle Hospital
PO Box 480
Fremantle WA 6959
Country 15638 0
Australia
Phone 15638 0
+61 8 9431 3733
Fax 15638 0
+61 8 9431 3711
Email 15638 0
[email protected]
Contact person for scientific queries
Name 6566 0
Yusuf Nagree
Address 6566 0
Fremantle Hospital Emergency Medicine Research Unit
Fremantle Hospital
PO Box 480
Fremantle WA 6959
Country 6566 0
Australia
Phone 6566 0
+61 8 9431 3733
Fax 6566 0
Email 6566 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.