Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000756325
Ethics application status
Approved
Date submitted
4/05/2017
Date registered
23/05/2017
Date last updated
5/02/2020
Date data sharing statement initially provided
30/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
ImpACTing Aboriginal and Torres Strait Islander patients presenting to an emergency department with a possible heart attack.. (The ImpACT-ATSI study).
Scientific title
The impact of ImpACT: Validation of an accelerated diagnostic protocol for Aboriginal and Torres Strait Islander patients presenting to an Emergency Department with suspected Acute Coronary Syndrome.
Secondary ID [1] 291741 0
Australian Centre for Health Services Innovation (AusHSI) Partnership Grant application: PG000839
Universal Trial Number (UTN)
U1111-1195-8981
Trial acronym
ImpACT-ATSI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suspected Acute Coronary Syndrome 302953 0
Chest Pain 302954 0
Condition category
Condition code
Cardiovascular 302426 302426 0 0
Coronary heart disease
Public Health 302738 302738 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
1. Patients who present to Cairns Emergency department with chest pain or symptoms of suspected ACS and who identify as Aboriginal or Torres Strait Islander who are clinically appropriate will be assessed as per the ImpACT pathway. The ImpACT pathway is an accelerated diagnostic protocol which has been implemented at the Cairns Hospital. Patients are risk stratified as either high, intermediate or low risk of suspected ACS and managed according to the protocol.

High Risk patients meet one or more of the following criteria: Elevated troponin (TnI); Ischaemic ECG changes; Left ventricular ejection fraction <40%; New Mitral Valve Regurgitation; Haemodynamic compromise; Syncope; Percutaneous Coronary Intervention within 6 months; Coronary Artery Bypass Grafting; Diabetes Mellitus with typical symptoms; Estimated Glomerular Filtration Rate ,60ml/min with typical symptoms and >or=40 years of age. High Risk patients are admitted under the care of Cardiology and receive repeat troponin testing 6 hours after presentation.

Intermediate Risk patients have no high risk features but one or more of the following criteria present: >or= 40 years of age; No Ischaemic ECG changes; First Troponin TnI
Low Risk patients have no intermediate or high risk features and are less than 40 years of age. These patients are cared for in the Emergency Department and receive a repeat TnI and ECG after 2 hours. If these tests are normal, patients are discharged and referred back to their General Practitioner for modification of cardiac risk factors.

Patients who are over 18 years of age or older, who identify as Aboriginal or Torres Strait Islander are NOT managed as low risk according to the ImpACT protocol. These patients are managed as either Intermediate Risk or High Risk of suspected ACS according to their other risk factors. This is the standard care that patients are currently receiving at Carins Hospital.

The research study is observational only and the care of patients does not change irrespective of their participation in the research. Patients will be invited to provide free and informed consent. The research nurse will record baseline data, the results of initial assessment (including biomarker results), data required for risk stratification and admission/discharge from the ED.

2. Research staff will contact ALL patients enrolled in the study by telephone at 30 days to identify subsequent attendances/admissions and adverse events up to 30 days after initial presentation.

3. Follow-up will occur at 30 days post initial presentation

4. Participants recruited from 2019 had a highly sensitive troponin assay collected due to a change in the assay across Pathology Queensland laboratories.

5. Newly recruited participants have also consented to follow up at 12 months following presentation.
Intervention code [1] 297854 0
Early Detection / Screening
Comparator / control treatment
No control group/not applicable.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301834 0
Cardiac Death
This outcome will be assessed via review of the medical records and adjudication by a cardiologist and/or physician.
Timepoint [1] 301834 0
At 30 days post initial presentation
Primary outcome [2] 301835 0
Acute Myocardial Infarction (AMI)
This outcome will be assessed via review of the medical records and adjudication by a cardiologist and/or physician.
Timepoint [2] 301835 0
At 30 days post initial presentation
Primary outcome [3] 301836 0
Urgent cardiovascular revascularisations
1. The composite primary outcome includes cardiac death, AMI and Urgent cardiovascular revascularisations and hospitalisations for Myocardial Ischaemia.
2. This outcome will be assessed via review of the medical records and adjudication by a cardiologist and/or physician.
Timepoint [3] 301836 0
At 30 days post initial presentation
Secondary outcome [1] 333987 0
1. The secondary outcome is: Admission to hospital with potential ACS. Admission to hospital with potential ACS includes patients diagnosed with Acute Myocardial Infarction in ED, diagnosed with ACS in ED, and those with significant EST findings.
2. The outcome will be determined on review of the medical records and adjudication by a cardiologist and/or physician.
Timepoint [1] 333987 0
During initial hospital presentation
Secondary outcome [2] 335145 0
Primary Outcome: Hospitalisations for Myocardial Ischaemia
This outcome will be assessed via review of the medical records and adjudication by a cardiologist and/or physician.
Timepoint [2] 335145 0
30 days post initial presentation

Eligibility
Key inclusion criteria
1. Patients will be included if they are aged 18 years and above, identify as Aboriginal and/or Torres Strait Islander, have presented to the Cairns Hospital Emergency Department and:
2. Present with symptoms of 5 minutes or more in duration consistent with possible ACS such as chest discomfort or angina equivalent; AND/OR; Physicians plan to evaluate the patient for suspected ACS
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded from the research study if:
1. They are pregnant
2. Aged less than 18 years old
3. A clear alternative non-ACS diagnostic cause for symptoms is determined
4. The researcher feels that recruitment is inappropriate (e.g. Terminal illness)
5. The patient (or legal representative) is unable or unwilling to provide informed consent
6. Patient (or legal representative) refusal of telephone follow up or medical record review at 30 days or unlikely to be contactable e.g. they will be overseas
7. The patient has been transferred from another hospital with sensitive troponin testing commenced at referring facility
8. The patient has been recruited to the trial within the last 30 days.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
According to 2011 Census data, 10% of the Cairns population identify as Aboriginal and Torres Strait Islander in comparison to <2% in Brisbane North. Approximately 200 patients a month present with chest pain to Cairns hospital. Due to the burden of disease being over represented in Aboriginal and Torres Strait Islander patients, we suspect >10% of this cohort will be of Aboriginal and Torres Strait Islander origin. To date, 160 patients have been recruited. Due the extension of recruitment time we estimate the total number of patients recruited will be approximately 320. With ACS event rates of approximately 15% in patients of non- Aboriginal and Torres Strait Islander we anticipate in our study there is >95% probability that we will identify >2 low to intermediate risk patients with ACS in this study.

Statistical Methods:
Descriptive statistics will be reported to provide demographic and clinical data on the patients stratified as low, intermediate or high risk according to the IMPACT protocol. The proportion of patients in the low, intermediate and high-risk groups meeting the primary and secondary outcomes will be reported with 95% confidence intervals

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2017
Actual
1/11/2017
Date of last participant enrolment
Anticipated
31/12/2019
Actual
31/12/2019
Date of last data collection
Anticipated
31/01/2020
Actual
31/12/2019
Sample size
Target
320
Accrual to date
Final
271
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 7876 0
Cairns Base Hospital - Cairns
Recruitment postcode(s) [1] 15823 0
4870 - Cairns

Funding & Sponsors
Funding source category [1] 296236 0
Government body
Name [1] 296236 0
Clinical Excellence Division through the Health Care Improvement Unit, Queensland Health
Country [1] 296236 0
Australia
Funding source category [2] 296241 0
University
Name [2] 296241 0
Queensland University of Technology
Country [2] 296241 0
Australia
Funding source category [3] 304877 0
Other Collaborative groups
Name [3] 304877 0
Brisbane Diamantina Health Partners
Country [3] 304877 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Australian Centre for Health Services Innovation - AusHSI
School of Public Health
Institute of Health and Biomedical Innovation
Queensland University of Technology
60 Musk Ave, Kelvin Grove
QLD 4059
Country
Australia
Secondary sponsor category [1] 295155 0
Hospital
Name [1] 295155 0
Cairns Hospital
Address [1] 295155 0
165 Esplanade, Cairns QLD 4870
Country [1] 295155 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297476 0
Far North Queensland Health Research and Ethics Committee
Ethics committee address [1] 297476 0
Ethics committee country [1] 297476 0
Australia
Date submitted for ethics approval [1] 297476 0
30/03/2017
Approval date [1] 297476 0
01/06/2017
Ethics approval number [1] 297476 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1928 1928 0 0
/AnzctrAttachments/372777-HREC Approval Cairns_1June2017.pdf (Ethics approval)

Contacts
Principal investigator
Name 74166 0
Prof Louise Cullen
Address 74166 0
C/O Department of Emergency Medicine,
Royal Brisbane and Women's Hospital,
Butterfield Street & Bowen Bridge Road
Herston, QLD, 4006
Country 74166 0
Australia
Phone 74166 0
+617 3646 8153
Fax 74166 0
Email 74166 0
[email protected]
Contact person for public queries
Name 74167 0
Louise Cullen
Address 74167 0
C/O Department of Emergency Medicine,
Royal Brisbane and Women's Hospital,
Butterfield Street & Bowen Bridge Road
Herston, QLD, 4006
Country 74167 0
Australia
Phone 74167 0
+617 3646 8153
Fax 74167 0
Email 74167 0
[email protected]
Contact person for scientific queries
Name 74168 0
Nicholas Graves
Address 74168 0
C/O Faculty of Health
Queensland University of Technology
Kelvin Grove
QLD, 4059
Country 74168 0
Australia
Phone 74168 0
+61 7 3138 6115
Fax 74168 0
Email 74168 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
Will review with HREC


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6765Ethical approval  [email protected] 372777-(Uploaded-06-01-2020-15-58-06)-Study-related document.pdf
6766Study protocol  [email protected] Please contact PI for request of study protocol



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.