Trial Review

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
ACTRN12610000036011
Ethics application status
Approved
Date submitted
21/12/2009
Date registered
13/01/2010
Date last updated
2/01/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Reducing Acute Coronary Syndrome Time in the Emergency Department for Patients with Non-Traumatic Chest Pain
Scientific title
In patients presenting to an Emergency department with non-traumatic chest pain, does the introduction of a new multimatker strategy compared with the current standard practice of an 8 hour troponin, safely reduce the length of time spent in the emergency department?
Secondary ID [1] 1263 0
none
Universal Trial Number (UTN)
U1111-1112-9370
Trial acronym
REACTED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chest Pain 256423 0
acute coronary syndrome 256424 0
Condition category
Condition code
Cardiovascular 256596 256596 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is the introduction of an accelerated multimarker based chest pain protocol, performing serum Myoglobin, Creatine kinase -MB and Troponin-I on arrival and either 2 hours later or at least 4 hours after the onset of the patients maximal pain, whichever is later
Intervention code [1] 255718 0
Diagnosis / Prognosis
Intervention code [2] 255719 0
Early detection / Screening
Comparator / control treatment
We will compare retrospectively with patients managed using the standard 8 hour troponin recommended by current Australian national guidelines prior to the introduction of the protocol from November 2009 till December 2009
Control group
Historical

Outcomes
Primary outcome [1] 257494 0
Major adverse cardiovascular events (MACE) - a composite end point of any of the following: Myocardial infarction, Cardiac death, cardiac arrest, major cardiac revascularization, cardiogenic shock, new ventricular arrhythmia requiring treatment, 2nd or 3rd degree heart block requiring intervention.
These events will be assessed by telephone followup of both the patient and the patient's General Practitioner (GP) as well as collection of data such as Electrocardiograms, cardiological investigations from their medical notes as well as a search through Western Australian Death registry for any patients lost to follow up, at the end of the trial.
Outcomes will be adjudicated by a consultant cardiologist and a consultant emergency physician not involved in data collection. Any disagreements will be resolved by another consultant cardiologist.
Timepoint [1] 257494 0
30 and 45 days post Emergency department (ED) attendance
Secondary outcome [1] 262689 0
Time spent in the Emergency department before and after the introduction of the multimarker strategy
Timepoint [1] 262689 0
Time spend in the Emergency department on the day of presentation
Secondary outcome [2] 262692 0
Major adverse cardiovascular events (MACE) - a composite end point of any of the following: Myocardial infarction, Cardiac death, cardiac arrest, major cardiac revascularization, cardiogenic shock, new ventricular arrhythmia requiring treatment, 2nd or 3rd degree heart block requiring intervention OR new onset of heart failure requiring treatment as adjudicated by the 2 consultants on our adjudciation panel.
Timepoint [2] 262692 0
30 and 45 days post ED attendance
Secondary outcome [3] 262693 0
Myocardial infarction and / or unstable angina as assessed by our adjudication panel of consultants after collection and review of medical notes, investigations such as electrocardiograms, angiograms, echocardiograms and results of blood tests and based on current internationally recognised definitions
Timepoint [3] 262693 0
30 and 45 days post ED attendance
Secondary outcome [4] 262694 0
Angiography with >70% lesion not revascularised due to comorbidity/ complexity as assessed by our adjudication panel of consultants after collection and review of medical notes, investigations such as electrocardiograms, angiograms, echocardiograms and results of blood tests
Timepoint [4] 262694 0
30 and 45 days post ED attendance

Eligibility
Key inclusion criteria
Age >/= 18
Presenting with non-traumatic chest pain
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age <18.
Traumatic cause of chest pain

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The intervention (ie: the multimarker pathway) is in widespread use internationally and is ranked as having the same level of evidence as our current practice by the current American College of Emergency Physicians (ACEP) guidelines. All patients presenting with non-traumatic chest pain will be managed with our new multimarker stategy. Our study is different in that it is using the latest generation of laboratory based super-sensitive troponin assays. Patients will be identified at triage and photocopies of their notes will be placed in the study form collection box by the doctor on completion.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
no randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2009
Actual
10/11/2009
Date of last participant enrolment
Anticipated
Actual
31/05/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 1884 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 7663 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 256203 0
Self funded/Unfunded
Name [1] 256203 0
Country [1] 256203 0
Primary sponsor type
Individual
Name
dr peter allely
Address
emergency department
sir charles gairdner hospital
hospital avenue
nedlands
WA 6009
Country
Australia
Secondary sponsor category [1] 251545 0
Individual
Name [1] 251545 0
dr david mountain
Address [1] 251545 0
emergency department
sir charles gairdner hospital
hospital avenue
nedlands
WA 6009
Country [1] 251545 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258305 0
Sir Charles Gairdner Group Human research ethics committee
Ethics committee address [1] 258305 0
Sir Charles Gairdner Hospital,
Hospital avenue
Nedlands
WA 6009
Ethics committee country [1] 258305 0
Australia
Date submitted for ethics approval [1] 258305 0
Approval date [1] 258305 0
20/08/2009
Ethics approval number [1] 258305 0
2531

Summary
Brief summary
Chest pain is one of the most common reasons for presentation to Australian emergency departments. Despite this little is known about the safety of our current practice, which often involves patients spending many hours in an Emergency department awaiting repeated blood tests and electrocardiograms. Recent introduction of a latest generation super-sensistive troponin to our laboratory combined with an interest in an accelerated 'multimarker stratgey' already in widespread use throughout the UK and the USA (that back in 2006 was ranked as having the same level of evidence as our current practice by the American college of Emergency Physicians) and a desire to increase efficiency we have redesigned the way our department manages patients presenting with non-traumatic chest pain that allows us to confidently discharge patients as soon as 4 hours after the onset of their symptoms.
This trial is intended to compare the efficacy and safety of this new process, when compared to the old process.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30631 0
A/Prof David Mountain
Address 30631 0
Emergency Department,
Sir Charles Gairdner Hospital,
Nedlands
WA 6009
Country 30631 0
Australia
Phone 30631 0
+61893462836
Fax 30631 0
Email 30631 0
[email protected]
Contact person for public queries
Name 13878 0
Dr peter allely
Address 13878 0
emergency department
sir charles gairdner hospital
hospital avenue,
nedlands
wa 6009
Country 13878 0
Australia
Phone 13878 0
+61 8 9346 2836
Fax 13878 0
Email 13878 0
[email protected]
Contact person for scientific queries
Name 4806 0
Dr peter allely
Address 4806 0
emergency department
sir charles gairdner hospital
hospital avenue,
nedlands
wa 6009
Country 4806 0
Australia
Phone 4806 0
+61 8 9346 2836
Fax 4806 0
Email 4806 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.