Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000797279
Ethics application status
Approved
Date submitted
19/01/2018
Date registered
10/05/2018
Date last updated
10/12/2019
Date data sharing statement initially provided
25/06/2019
Date results information initially provided
10/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Single Troponin Accelerated Triage of Chest Pain (STAT-Chest Pain) Study: Assessment of the safety and efficacy of an innovative pathway used to triage patients presenting to the Emergency Department with chest pain.
Scientific title
Single Troponin Accelerated Triage of Chest Pain (STAT-Chest Pain) Study: Assessment of the safety and efficacy of an innovative pathway used to triage patients presenting to the Emergency Department with chest pain.
Secondary ID [1] 293804 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
STAT-Chest Pain
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Acute coronary syndrome 306219 0
Chest pain 306220 0
Myocardial ischaemia 306712 0
Angina pectoris 306713 0
Condition category
Condition code
Cardiovascular 305320 305320 0 0
Coronary heart disease
Public Health 305817 305817 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The single troponin accelerated triage of chest pain study is a prospective cohort study with pre- and post-"STAT pathway" arms.

We will implement a clinical pathway for assessment of patients with “Suspected ACS” which will include a “single troponin” arm for patients presenting more than 2 hours after the onset of their symptoms. This will be known as the STAT pathway.

This study will aim to capture all patients presenting to Royal Perth Hospital Emergency Department with symptoms suggestive of ACS who are managed as part of the “Suspected ACS” pathway. In the pre- arm, the Suspected ACS pathway will be the pathway recommended by the Australian National Heart Foundation. In the post-intervention arm, the Suspected ACS pathway will be a new pathway as described above - the "STAT pathway".
The pre-STAT arm will run for approx 3 months. The post-STAT arm will run for approx 12 months.

Initial contact with patients will be made by either an ED clinician, cardiology clinician, research nurse or ED nurse. The “Suspected ACS Pathway” pathway incorporates early detailed clinical assessment in the RPH emergency department by an ED clinician, plus the following:
• Initial (0 hours) high sensitivity cardiac troponin I (hs cTnI) measurement
• Basic blood tests, including full blood count
• Chest X-ray and ECG
• Objective chest pain risk score (TIMI or HEART score)
• Objective assessment of the risk of pulmonary embolism
• Consideration (based on clinical assessment and basic tests) of other important conditions (e.g. aortic dissection, pneumothorax, pneumonia or GI pathology)

Given the large numbers of patients expected (~10-15 patients a day) and the impracticalities of delivering an explicit consent across all 24 hours of the day in a busy tertiary emergency department, all participants will be consented as part of an opt-out consent process.

After their initial assessment, patients will be managed according to the clinical judgment of the treating doctor, taking into consideration the treatment pathway.

All patients recruited in the post-intervention phase who are discharged directly from the ED will receive follow up by the research team in the form of a phone call or sms. If patients have ongoing symptoms or symptoms of concern, they will be invited back for assessment in the outpatient clinic.
All high or intermediate risk patients discharged home will be followed up in the outpatient clinic.
Intervention code [1] 300060 0
Diagnosis / Prognosis
Comparator / control treatment
Current “Suspected ACS Pathway” chest pain pathway recommended by the National Heart Foundation of Australia and Cardiac Society of Australia and New Zealand. Data will be collected for at least 3 months prior to the implementation of the new pathway.

1. Chew DP, Scott IA, Cullen L, French JK, Briffa TG, Tideman PA, Woodruffe S, Kerr A, Branagan M and Aylward PE. National Heart Foundation of Australia & Cardiac Society of Australia and New Zealand: Australian Clinical Guidelines for the Management of Acute Coronary Syndromes 2016. Heart, lung & circulation. 2016;25:895-951.
Control group
Historical

Outcomes
Primary outcome [1] 304481 0
Primary efficacy outcome: The proportion of patients presenting with a suspected / possible NSTEACS who are discharged from ED in < 3 hours. This data will be gathered from hospital admission records.
Timepoint [1] 304481 0
Patients discharged from ED in < 3 hours from presentation to ED. Data will be collected retrospectively 24-72 hrs after the patient has been discharged.
Primary outcome [2] 305233 0
Primary safety outcome: The percentage of patients who are discharged directly from the ED who suffer a major adverse cardiac event (defined as all cause death or acute MI), This data will be gathered by a 30 day follow up phone call and through data linkage with state-based data warehouses.
Timepoint [2] 305233 0
30 Days from initial hospital presentation.
Secondary outcome [1] 342075 0
The median duration of time spent in ED by all patients presenting with a suspected / possible NSTEACS (whether admitted to hospital or discharged directly from ED). This will be defined as the median length of time from presentation to RPH ED to discharge from RPH ED .
Timepoint [1] 342075 0
Median time spent in ED from initial hospital presentation to discharge from ED. Data will be collected retrospectively 24-72 hrs after the patient has been discharged.
Secondary outcome [2] 344548 0
The median duration of time spent in ED by patients presenting with a suspected / possible NSTEACS who have hs-cTnI level < upper limit normal. This will be defined as the median length of time from presentation to RPH ED to discharge from RPH ED for both patient groups.
Timepoint [2] 344548 0
Median time spent in ED from initial hospital presentation to discharge from ED. Data will be collected retrospectively 24-72 hrs after the patient has been discharged.
Secondary outcome [3] 344549 0
Major adverse cardiac events (death or MI) at 1 year from initial hospital presentation. All cause death determined by linked data and MI defined using 3rd universal definition.
Timepoint [3] 344549 0
1 year from initial hospital presentation
Secondary outcome [4] 344550 0
Composite outcome of ED presentations or hospital admissions for chest pain or any cause at 1 year from initial hospital presentation. Data for this outcome will be gathered through linkage to data held in government (department of health) databases.
Timepoint [4] 344550 0
1 year from initial hospital presentation
Secondary outcome [5] 344551 0
Costs of the conventional and accelerated discharge protocol (at 30-days, 1 year and 2 years). During the index hospital stay data will be collected using a standardised data collection tool. The study nurse will collect data regarding in-patient investigation such as exercise stress testing, myocardial perfusion scanning, CT coronary angiography or conventional angiography. At 30 day and 1 year follow up patients will be asked about any subsequent investigations (which may be performed at other public hospitals or privately). They will also be asked about subsequent re-presentations to ED or admissions to hospital for cardiac symptoms. Again these data will be collected using a standardised questionnaire. Data linkage will also ensure that we are able to track resource usage (in-patient procedures, ED presentations and hospital admissions) during the subsequent 2 years following the index admission.
Timepoint [5] 344551 0
30 days, 1 year and 2 years from initial hospital presentation
Secondary outcome [6] 346643 0
The median duration of time spent in ED by patients presenting with a suspected / possible NSTEACS who are subsequently discharged without admission to hospital. This will be defined as the median length of time from presentation to RPH ED to discharge from RPH ED .
Timepoint [6] 346643 0
Median time spent in ED from initial hospital presentation to discharge from ED. Data will be collected retrospectively 24-72 hrs after the patient has been discharged.
Secondary outcome [7] 346644 0
The median duration of time spent in hospital by all patients presenting with a suspected / possible NSTEACS (whether admitted to hospital or discharged directly from ED). This will be defined as the median length of time from presentation to RPH ED to discharge from hospital .
Timepoint [7] 346644 0
Data will be collected retrospectively 24-72 hrs after the patient has been discharged.
Secondary outcome [8] 346645 0
The median duration of time spent in ED by patients presenting with a suspected / possible NSTEACS who have hs-cTnI level < 5ng/L. This will be defined as the median length of time from presentation to RPH ED to discharge from RPH ED.
Timepoint [8] 346645 0
Median time spent in ED from initial hospital presentation to discharge from ED. Data will be collected retrospectively 24-72 hrs after the patient has been discharged.

Eligibility
Key inclusion criteria
This study will aim to recruit all adult patients (>18 years old), presenting to the Royal Perth Hospital Emergency Department with chest pain who are managed as part of the "Suspected ACS pathway" for the duration of the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• < 18 years old
• ST-elevation myocardial infarction (STEMI) diagnosed on, or prior to, arrival in ED
• Clear non-cardiac cause of chest pain / no indication for troponin measurement
• Need for hospital admission due for reasons apart from chest pain (e.g. other medical problems requiring admission and investigation)
• Patients with impaired capacity or unable to provide opt out consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This study has a 'before and after' design. We will be assessing the time that patients spend in ED and hospital, clinical outcomes and resource use in patients presenting with chest pain initially treated using a conventional, guideline based, chest pain pathway and then using a novel accelerated pathway.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The demographic and clinical characteristics of the patients presenting to the ED at RPH with chest pain during the two time periods (pre- and post-intervention) will be compared using standard parametric and non-parametric tests as appropriate (depending on the distribution of the data). The proportion of patients discharged within 3 hours and the number of patients suffering a major adverse cardiac event at 30 days during each time period will be compared using the chi-square or Fishers exact test as appropriate. Standard statistical tests will also be used to compare the secondary outcomes. Statistical testing will be two-sided at the 5% level of significance.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/05/2018
Actual
14/05/2018
Date of last participant enrolment
Anticipated
2/12/2019
Actual
18/10/2019
Date of last data collection
Anticipated
2/12/2020
Actual
6/12/2019
Sample size
Target
2500
Accrual to date
Final
2264
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 9807 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 18585 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 298421 0
Government body
Name [1] 298421 0
WA Department of Health
Country [1] 298421 0
Australia
Primary sponsor type
Hospital
Name
Department of Cardiology, Royal Perth Hospital
Address
Level 4, South Block,
Wellington Street, PERTH,
WA, 6000
Country
Australia
Secondary sponsor category [1] 297559 0
Hospital
Name [1] 297559 0
Department of Emergency Medicine, Royal Perth Hospital
Address [1] 297559 0
Level 3, South Block,
Wellington Street, Perth
WA 6000
Country [1] 297559 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299417 0
Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [1] 299417 0
Level 2 Kirkman House,
Royal Perth Hospital,
GPO Box X2213 Perth WA 6847
Ethics committee country [1] 299417 0
Australia
Date submitted for ethics approval [1] 299417 0
17/04/2017
Approval date [1] 299417 0
16/06/2017
Ethics approval number [1] 299417 0
RGS0000000148

Summary
Brief summary
Acute chest pain is one of the commonest causes of presentation to Emergency Departments (EDs) locally (~7.5% of all attendances to Royal Perth Hospital ED in 2015), nationally and worldwide. The majority (>75%) of these individuals are at low risk of serious complications, with only a small proportion ultimately diagnosed with an acute coronary syndrome (ACS) or other major pathology. The consequences of misdiagnosis are, however, potentially catastrophic. Thus, considerable time and resources are expended to ensure the accurate triage of such patients.

Recent data from Shah et al suggests that patients with very low levels of high sensitivity troponin (hs-cTn; a very sensitive and specific blood marker of cardiac injury) on arrival to ED (the majority of all those with presenting with chest pain) are at extremely low risk and could be safely and quickly discharged. They found that of all patients presenting with suspected acute coronary syndromes, 61% had a high sensitivity troponin I of <5 ng/L which had a negative predictive value of 99.6% (95% CI 99.3-99.8) for index myocardial infarction and subsequent myocardial infarction or cardiac death at 30 days. If their serum troponin measurement was taken more than 2 hours after the onset of symptoms then this increased the negative predictive value to 99.8% (95% CI 99.6-100%).
Based on this research and current best practice, our group has developed a rapid assessment “single troponin” chest pain pathway that will be introduced at Royal Perth Hospital in early 2018. Using a pre/post cohort study design we will observe the efficacy and safety of this innovative pathway, which offers the most accelerated triage of patients with chest pain currently available, and compare it with the current National Heart Foundation of Australia / Cardiac Society of Australia and New Zealand Guidelines based “Suspected ACS Pathway” which represents current best practice. We hypothesise that using a combination of hs-cTnI levels, careful clinical assessment, objective risk scores and structured, evidence-based, early follow up and investigation will greatly reduce the length of stay for low risk patients without any increase in adverse outcomes.

If this proves correct this novel pathway will result in considerable efficiencies and cost savings that can be easily replicated in other hospitals.
Trial website
Not available
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80330 0
Prof Graham Hillis
Address 80330 0
Department of Cardiology
Royal Perth Hospital
Level 4, South Block,
Wellington Street, PERTH,
WA, 6000
Country 80330 0
Australia
Phone 80330 0
+618 9224 2244
Fax 80330 0
Email 80330 0
[email protected]
Contact person for public queries
Name 80331 0
Ms Michelle Bonner
Address 80331 0
Department of Cardiology - Research Office
Level 4, South Block,
Wellington Street, PERTH,
WA, 6000
Country 80331 0
Australia
Phone 80331 0
+618 9224 2244
Fax 80331 0
Email 80331 0
[email protected]
Contact person for scientific queries
Name 80332 0
Prof Graham Hillis
Address 80332 0
Department of Cardiology
Royal Perth Hospital
Level 4, South Block,
Wellington Street, PERTH,
WA, 6000
Country 80332 0
Australia
Phone 80332 0
+618 9224 2244
Fax 80332 0
Email 80332 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
HREC approval does no allow data to be shared with third parties.


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
SourceTitleYear of PublicationDOI
EmbaseSingle high-sensitivity troponin levels to assess patients with potential acute coronary syndromes.2021https://dx.doi.org/10.1136/heartjnl-2020-317997
N.B. These documents automatically identified may not have been verified by the study sponsor.