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Trial registered on ANZCTR


Registration number
ACTRN12613000745741
Ethics application status
Approved
Date submitted
27/06/2013
Date registered
4/07/2013
Date last updated
4/07/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can a new "Emergency Department Assessment of Chest-pain Score (EDACS)" reduce hospital admissions and observation for patients presenting with possible heart attack?
Scientific title
In people presenting to the Emergency Department (ED) at Christchurch Hospital with chest pain, can a the use of a new "Emergency Department Assessment of Chest-pain Score (EDACS)" compared to the TIMI score increase the proportion of patients “successfully” discharged home within 6 hours of ED arrival with no Major Adverse Cardiac Event (MACE) during the following 30 days?
Secondary ID [1] 281153 0
Nil
Universal Trial Number (UTN)
U111111339936
Trial acronym
EDACS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac Chest Pain 287314 0
Condition category
Condition code
Cardiovascular 287655 287655 0 0
Coronary heart disease
Public Health 289819 289819 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to an initial assessment using either the control or experimental Accelerated Diagnostic Pathways (ADPs). The difference between the ADP's is risk assessment score that is used. This is the modified TIMI score in the control arm and the EDACS score in the experimental arm

Control ADP: is described below.

Experimental ADP uses EDACS score and ECG and troponin:

EDACS score

Age Score
18-45 =+2
46-50 =+4
51-55 =+6
56-60 =+8
61-65 =+10
66-70 =+12
71-75 =+14
76-80 =+16
81-85 =+18
86+ =+20

3 Risk factors and 18-50 =+4
3 Risk factors and 51+ =+0

Diaphoresis =+3
Radiates to arm or shoulder =+5
Occurred with inspiration (pleuritic) =-4
Reproduced by palpation =-6

Male sex =+6

1) EDACS score <16
2) normal cardiac troponin (cTn) at 0 and 2 hours after arrival, and

3) no new ischaemic changes on ECGs.

If ALL three parameters above are met then the patient is classified as low-risk. Low risk patients will be eligible for early discharge to outpatient investigations after the 2-hour troponin result is available. Non low-risk patients will require further cTn testing after at least 6 hours following first or worst symptoms

Intervention code [1] 285697 0
Diagnosis / Prognosis
Intervention code [2] 287405 0
Early detection / Screening
Comparator / control treatment
Control ADP Pathway:
Modified TIMI score and ECG and troponin as below:

(A) MODIFIED TIMI SCORE=0
(A modified TIMI score is used without the Biomarker/ECG components. This is because these components are already incorporated in the pathway in a more comprehensive form.)
Clinical Characteristics:
Score ONE for every positive response
Score ZERO for any negative or ‘unknown’ response
a) Age 65 years or over
b) 3 of the following 5 CAD risk factors

The risk factors are:
(i) Family history: i.e., at age less than 55 years of age:
(1) Angina, (2) MI, (3) Sudden cardiac death without obvious cause
(ii) Hypertension
(iii) Hyperlipidemia
(iv) Diabetes
(v) Active smoker

c) Known CAD (stenosis 50% or higher):
e.g. a positive investigation or procedure for CAD including:
PCI, stent, positive angiogram, positive exercise tolerance test

d) ASA (i.e., Acetylsalicylic Acid / Aspirin) use in past 7 days
(Single GP or ambulance dose not included)

e) Recent severe angina (e.g. 2 or more events in last 24 hrs)



(B) normal cardiac troponin (cTn) concentrations at 0 and 2 hours after arrival, and

(C) no new ischaemic changes on ECGs.

If ALL three parameter above are met then the patient is classified as low-risk. Low risk patients will be eligible for early discharge to outpatient investigations after the 2-hour troponin result is available. Non low-risk patients will require cTn testing on hospital arrival and again after at least 6 hours following first or worst symptoms
Control group
Active

Outcomes
Primary outcome [1] 287991 0
Primary objective: Compare the effectiveness, when applied to clinical practice, of an accelerated diagnostic protocol within a clinical pathway that uses the EDACS score against the standard accelerated diagnostic process at Christchurch Hospital which incorporates the Thrombolysis In Myocardial Infarction (TIMI) score.
Timepoint [1] 287991 0
The proportion of patients successfully discharged home after ED assessment within 6 hours of ED arrival with no Major Adverse Cardiac Event (MACE) during the following 30 days.
Secondary outcome [1] 299214 0
Major Adverse Cardiac Event (MACE) including:

(i) death (unless clearly non-cardiac),
(ii) cardiac arrest,
(iii) emergency revascularization procedure,
(iv) cardiogenic shock,
(v) ventricular arrhythmia needing intervention,
(vi) high-degree atrioventricular block needing intervention,
(vii) acute myocardial infarction.

AMI classified using the global taskforce recommendations requiring evidence of myocardial necrosis together with clinical evidence of myocardial ischemia (ischemic symptoms, ECG changes, or imaging evidence).
Timepoint [1] 299214 0
30 days
Secondary outcome [2] 299216 0
Acute coronary syndrome related hospital re-attendance, (including unstable angina and urgent revascularization)
Timepoint [2] 299216 0
at 30 days post admission
Secondary outcome [3] 299217 0
All cause hospital re-attendance
Timepoint [3] 299217 0
at 30 days post admission
Secondary outcome [4] 299218 0
cost effectiveness (a health economist is being contracted by the Canterbury District Health Board (CDHB)
Timepoint [4] 299218 0
30 days
Secondary outcome [5] 299219 0
health utility measured using the EQ-5D self-complete questionnaire at three months after attendance
Timepoint [5] 299219 0
at 90 days post attendance
Secondary outcome [6] 299220 0
satisfaction with care measured at three months after attendance using a modified Group Health Association questionnaire that has been used successfully in previous studies of diagnostic strategies for acute chest pain
Timepoint [6] 299220 0
3 months post attendance
Secondary outcome [7] 299221 0
ethnicity and socio-economic representation.
Timepoint [7] 299221 0
3 months post attendance

Eligibility
Key inclusion criteria
Adults (age 18 years or older) presenting acutely from the community to the Emergency Department (ED) with chest pain suggestive of acute coronary syndrome for whom, the attending clinician(s) intend(s) to perform serial troponin analysis (cTns), to investigate for possible acute myocardial infarction.

In accordance with American Heart Association guidelines, possible cardiac symptoms include: the presence of acute chest, epigastric, neck, jaw or arm pain or discomfort or pressure without apparent non-cardiac source.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
ST Segment Elevation Myocardial Infarction (STEMI) present on any electrocardiograph (ECG). (These patients are at very high risk and guidelines mandate immediate transfer to cardiology facilities for treatment and/ monitoring)

Patients with proven or suspected non-coronary pathology as the cause of chest pain

Patients who will require admission regardless of a negative cTn, due to other medical conditions, or need for other investigations

Transfers from other departments or hospitals and patients attending with an acute troponin result already known to be raised before arrival.

Subjects previously enrolled in this study

Anticipated problem with follow-up e.g. resident outside New Zealand
Patient (or Legal Representative) unable or unwilling to provide informed consent

Patients for whom the researcher does not think that recruitment is appropriate for non-medical reasons (e.g. poor mental status, emotionally vulnerable)

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The research nurses will monitor the Emergency Department queue screen to identify patients attending with possible chest pain and screen these patients. Only a limited numbers of characters from the triage nurse assessment are visible on the ED queue screen meaning that a presentation of “Chest pain and shortness of breath after being kicked in chest by cow, possible rib fracture and pneumothorax” will appear as “Chest pain”. The research nurses will not know until they approach and screen the patient for eligibility if there is suspected cardiac chest pain due to a possible AMI. For this reason, it will immediately be obvious that many screened patients are not suitable for enrolment. The attending clinician will be allowed time to decide if the patient requires investigation for possible AMI and for liaison with the research nurse about trial eligibility. The nurses will record demographic details and reason for exclusion, allowing completion of a Consolidated Standards of Reporting Trials (CONSORT) flowchart.

Patient consent to participate in trial randomisation will be obtained in writing by the study nurses after the patient has been provided with an information sheet and a verbal explanation of the trial. Patients will always have the opportunity to withdraw from the study at any time and for any reason.

Research Nurses will randomise patients using a sequential sealed envelope process. Study packs will be kept in a locked filing cabinet. They numbered opaque envelope containing the randomisation allocation will be contained within an opaque folder with a matching number within the study packs.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be generated by a biostatistician and the allocation envelopes will be prepared by a member of the study group that is not involved with patient recruitment or outcomes adjudication. The method used to create the random order for the allocation of subjects into different groups will be permuted block randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Blinding of clinical staff will not be possible, however the primary objectives will be determined by adjudicators blind to the study group assignment and the analyses will be performed by investigators blind to the study group assignment
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
RCT analysis plan:

Study participants’ baseline characteristics will be summarized using standard descriptive statistics. Successful discharge and occurrence of MACE will be compared between study groups using the chi squared test or Fisher’s exact test, and the odds ratio with 95% confidence intervals. The time from attendance to hospital discharge will be displayed using Kaplan-Meier curves. The primary analysis will be undertaken on an intention-to-treat basis.

Current research predicts an 18% discharge rate at 6 hours in the control arm (experimental arm of the current RCT). Even if the experimental arm achieved early discharge in 30% of patients (rather than the 40+% as predicted) this would be an important difference. This study will be powered to detect a 13% difference between the early discharge rates with a Beta=0.10 (90% power) and a 2-tailed Alpha=0.05. This will require recruitment of 265 patients in each arm and 530 patients in total. Based on recruitment in our current study this will take approximately 18 months.


Recruitment
Recruitment status
Recruiting
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 outside Australia
Country [1] 4526 0
New Zealand
State/province [1] 4526 0
Canterbury

Funding & Sponsors
Funding source category [1] 286013 0
Government body
Name [1] 286013 0
New Zealand Health Research Council
Address [1] 286013 0
Level 3 - ProCARE Building, Grafton Mews, at 110 Stanley Street, Auckland 1010
Country [1] 286013 0
New Zealand
Primary sponsor type
Government body
Name
New Zealand Health Research Council
Address
Level 3 - ProCARE Building, Grafton Mews, at 110 Stanley Street, Auckland 1010
Country
New Zealand
Secondary sponsor category [1] 284830 0
Hospital
Name [1] 284830 0
Canterbury District Health Board
Address [1] 284830 0
Riccarton Avenue
Private Bag 4710
Christchurch
Country [1] 284830 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288065 0
Central Regional Health and Disability Ethics Committee
Ethics committee address [1] 288065 0
Ministry of Health
No 1 The Terrace
PO Box 5013
6145
Wellington
Ethics committee country [1] 288065 0
New Zealand
Date submitted for ethics approval [1] 288065 0
30/08/2012
Approval date [1] 288065 0
10/12/2012
Ethics approval number [1] 288065 0
12/CEN/23

Summary
Brief summary
This research investigates an innovative and worklable change to the medical decision making process for patients presenting the Emergency Departments with chest pain that is possibly due to a heart attack. This randomised trial aims to prove the effectiveness of a new "fast-track" (2-hour) pathway compared with the existing "fast-track" pathway that is used in current standard care. It uses a specially purpose developed Emergency Department Assessment of Chest-pain Score (EDACS) to identify low-risk patients rather than the risk score currently used in clinical practice that was not designed for this purpose. This should double the number of patients that can have a heart attack rules out earlier (up to 10 hours earlier) than is usually possible. The EDACS score (and the safety of it's use) has already been observationally validated in a two centre cohort of >600 patients separate from the patient group in which it was developed. If successful this new pathweay would make a tangible contribution to health care by preventing unnecessary hospital admission and facilitating early discharge home in a large group of patients. This outcome is beneficial to both patients and the health service, by reassuring patients earlier that heart attack has been ruled out and by avoiding unnecessary admission, duplication of staff activities, and reducing pressure upon urgent care services.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34657 0
Dr Martin Than
Address 34657 0
Emergency Department
Christchurch Hospital
Private Bag 4710
Christchurch
Country 34657 0
New Zealand
Phone 34657 0
+6421450685
Fax 34657 0
Email 34657 0
martinthan@xtra.co.nz
Contact person for public queries
Name 17904 0
Dr Dr Martin Than
Address 17904 0
Emergency Department
Christchurch Hospital
Private bag 4710
Christchurch
Country 17904 0
New Zealand
Phone 17904 0
+643 364 0270
Fax 17904 0
Email 17904 0
martinthan@cdhb.govt.nz
Contact person for scientific queries
Name 8832 0
Dr Dr Martin Than
Address 8832 0
Emergency Department
Christchurch Hospital
Private bag 4710
Christchurch
Country 8832 0
New Zealand
Phone 8832 0
+643 364 0640
Fax 8832 0
Email 8832 0
martin.than@cdhb.health.nz

No information has been provided regarding IPD availability
'Other' documents specified
See publication
Summary results
No Results