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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]

Nil

Universal Trial Number (UTN)

U111111339936

Trial acronym

EDACS

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cardiac Chest Pain

Condition category

Condition code

Cardiovascular

Coronary heart disease

Public Health

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]

Diagnosis / Prognosis

Intervention code [2]

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]

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]

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]

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]

30 days

Secondary outcome [2]

Acute coronary syndrome related hospital re-attendance, (including unstable angina and urgent revascularization)

Timepoint [2]

at 30 days post admission

Secondary outcome [3]

All cause hospital re-attendance

Timepoint [3]

at 30 days post admission

Secondary outcome [4]

cost effectiveness (a health economist is being contracted by the Canterbury District Health Board (CDHB)

Timepoint [4]

30 days

Secondary outcome [5]

health utility measured using the EQ-5D self-complete questionnaire at three months after attendance

Timepoint [5]

at 90 days post attendance

Secondary outcome [6]

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]

3 months post attendance

Secondary outcome [7]

ethnicity and socio-economic representation.

Timepoint [7]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/07/2013

Actual

1/07/2013

Date of last participant enrolment

Anticipated

1/01/2015

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

530

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Canterbury

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

New Zealand Health Research Council

Address [1]

Level 3 - ProCARE Building, Grafton Mews, at 110 Stanley Street, Auckland 1010

Country [1]

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]

Hospital

Name [1]

Canterbury District Health Board

Address [1]

Riccarton Avenue
Private Bag 4710
Christchurch

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Regional Health and Disability Ethics Committee

Ethics committee address [1]

Ministry of Health
No 1 The Terrace
PO Box 5013
6145
Wellington

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

30/08/2012

Approval date [1]

10/12/2012

Ethics approval number [1]

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

Dr Martin Than

Address

Emergency Department
Christchurch Hospital
Private Bag 4710
Christchurch

Country

New Zealand

Phone

+6421450685

Fax

martinthan@xtra.co.nz

Contact person for public queries

Name

Dr Dr Martin Than

Address

Emergency Department
Christchurch Hospital
Private bag 4710
Christchurch

Country

New Zealand

Phone

+643 364 0270

Fax

martinthan@cdhb.govt.nz

Contact person for scientific queries

Name

Dr Dr Martin Than

Address

Emergency Department
Christchurch Hospital
Private bag 4710
Christchurch

Country

New Zealand

Phone

+643 364 0640

Fax

martin.than@cdhb.health.nz

No information has been provided regarding IPD availability

What supporting documents are/will be available?

Current supporting documents:

Updated to:

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
23243	Other	Than MP, Pickering JW, Aldous SJ, Cullen LA, Frampton CMA, Peacock WF, et al. Effectiveness of EDACS versus ADAPT accelerated diagnostic pathways for chest pain: A pragmatic randomized controlled trial embedded within practice. Annals of Emergency Medicine. 2016;68(1):93-102.e1.	https://www.ncbi.nlm.nih.gov/pubmed/26947800
23803	Other				See publication: Than MP, Pickering JW, Aldous SJ,... [More Details]

Results publications and other study-related documents

Documents added manually

Current Study Results

No documents have been uploaded by study researchers.

Update to Study Results

Doc. No.	Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
4377	Study results article	Yes		Than MP, Pickering JW, Aldous SJ, Cullen LA, Framp... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Diagnostic and prognostic performance of the ratio between high-sensitivity cardiac troponin I and troponin T in patients with chest pain	2022	https://doi.org/10.1371/journal.pone.0276645
Dimensions AI	Effectiveness of EDACS Versus ADAPT Accelerated Diagnostic Pathways for Chest Pain: A Pragmatic Randomized Controlled Trial Embedded Within Practice	2016	https://doi.org/10.1016/j.annemergmed.2016.01.001

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically