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Trial registered on ANZCTR


Registration number
ACTRN12611000206921
Ethics application status
Approved
Date submitted
16/02/2011
Date registered
22/02/2011
Date last updated
28/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A clinical decision tool for rapid assessment of cardiac chest pain.
Scientific title
Rapid assessment of cardiac chest pain: A prospective validation trial.
Secondary ID [1] 259619 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute coronary syndrome 261177 0
Condition category
Condition code
Cardiovascular 259332 259332 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients presenting to the Emergency Department will be assessed using a newly developed risk stratification process for acute coronary syndrome.
Patients will be deemed HIGH risk according to the high risk criteria of the National Heart Foundation/CS-ANZ guidelines 2006. Patients will be deemed VERY LOW risk if: Age <40, no history of DM, no renal impairment, normal (<= 0.04mcg/L) initial troponin and normal ECG. All others are INTERMEDIATE risk. This risk stratification will be applied in the Emergency Department on presentation, with ECG and troponin results available. This intervention is administered for the period of the index presentation.
Intervention code [1] 258052 0
Diagnosis / Prognosis
Comparator / control treatment
Historical case controls using NHF-A risk stratification process, prospectively recruited during 2008 - 2010 from the Emergency Department of the Royal Brisbane and Women's Emergency department.
Control group
Historical

Outcomes
Primary outcome [1] 262134 0
Diagnosis of ACS-related events, using the AHA/ACC/ESC/WHO task force universal definition of myocardial infarction.
The primary endpoint is adjudicated by cardiologists using all available investigations, telephone follow up calls and clinical notes for 30 day events.
Timepoint [1] 262134 0
30 days
Secondary outcome [1] 273216 0
The secondary outcome will include a composite outcome of those admitted to hospital for potential ACS. That is, those diagnosed with AMI or ACS on admission or those who have a significant EST finding. This endpoint is adjudicated by cardiologists using all available investigations, telephone follow up calls and clinical notes for 30 day events.
Timepoint [1] 273216 0
30 days

Eligibility
Key inclusion criteria
Patient with symptoms of greater than or equal to 5 minutes consistent with possible ACS (chest discomfort or angina equivalent)
AND/OR
Physician plans to evaluate the patient for potential ACS
AND
Intermediate risk features on QLD CPP
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
More than 2 hours since arrival at hopsital.

Patient (or Legal Representative) is unable or unwilling to provide informed consent.

Transfer from other hosptial.

Patient (or Legal Representative) refusal of telephone follow-up or medical record review at 30 days or unlikely to be contactable for follow-up.

Reasearcher does not feel that informed consent is obtainable or that recruitment is apporpriate (e.g. terminal illness).

Pregnant.

Clear alternative non-ACS diagnostic cause for symptoms.

High risk features according to QLD CPP.

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)
Procedure for enrolling a subject commences with introduction of a research nurse/staff member to eligible patients. The research nurse/staff member will provide the patient with an information sheet as well as a verbal briefing of the study and how the patient's care will change. Once the patient is confident they understand the study and its components, the patient is presented with a consent form which is signed, dated and witnessed. The patient will consent to their participation in the study, to being contacted in the furture, and for the storage of their blood.

Once the patient has been consented, a newly developed rule will be applied to further risk stratify patients presenting to the ED with chest pain who are initially assessed as intermediate risk group for ACS. The advanced risk stratification will place patients in either a very low risk group or an intermediate risk group. Treatment will be allocated based on which group the patients has been placed.

Patients initially assessed as high risk group for ACS will be treated as per usual care.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Nonrandomised trial.
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258512 0
Government body
Name [1] 258512 0
Queensland Emergency Medicine Research Foundation Ltd
Address [1] 258512 0
Level 1, 80 Jephson Street
Toowong Qld 4066
Country [1] 258512 0
Australia
Primary sponsor type
Individual
Name
Investigator initiated study - Dr Louise Cullen, Senior Staff Specialist
Address
Department of Emergency Medicine
Royal Brisbane and Women's Hospital
Herston Rd, Herston Queensland 4006
Country
Australia
Secondary sponsor category [1] 257653 0
None
Name [1] 257653 0
Address [1] 257653 0
Country [1] 257653 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260484 0
Human Reseach Ethics Committee
Ethics committee address [1] 260484 0
Royal Brisbane and Women's Hospital
Herston Rd, Herston Queensland 4029
Ethics committee country [1] 260484 0
Australia
Date submitted for ethics approval [1] 260484 0
07/10/2010
Approval date [1] 260484 0
27/01/2011
Ethics approval number [1] 260484 0
HREC/10/QRBW/403

Summary
Brief summary
The aim of this study is to prospectively investigate the accuracy and safety of an accelerated chest pain diagnostic pathway in patients presenting with intermediate risk chest pain in an Australian setting.
The primary objective is to demonstrate the sensitivity, specificity and predictive values of the rule for ACS-related diagnoses at 30 days post discharge.
The secondary objective is to demonstrate the sensitivity, specificity and predictive values of the rule for the composite oucome of patients who are admitted to hospital for potential ACS. That is, those with an ACS related diagnosis or significant exercise stress test (EST) findings (positive or indeterminate results).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32224 0
A/Prof Louise Cullen
Address 32224 0
Royal Brisbane and Women's Hospital, Butterfield Street, Herston QLD 4006
Country 32224 0
Australia
Phone 32224 0
+61 7 3646 7901
Fax 32224 0
Email 32224 0
louise.cullen@health.qld.gov.au
Contact person for public queries
Name 15471 0
A/Prof Louise Cullen
Address 15471 0
Department of Emergency Medicine
Royal Brisbane and Women's Hospital
Butterfield St, Herston Queensland 4029
Country 15471 0
Australia
Phone 15471 0
+61 7 3636 7901
Fax 15471 0
Email 15471 0
louise_cullen@health.qld.gov.au
Contact person for scientific queries
Name 6399 0
A/Prof Louise Cullen
Address 6399 0
Department of Emergency Medicine
Royal Brisbane and Women's Hospital
Butterfield St, Herston Queensland 4029
Country 6399 0
Australia
Phone 6399 0
+61 7 3636 7901
Fax 6399 0
Email 6399 0
louise_cullen@health.qld.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary