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Trial registered on ANZCTR


Registration number
ACTRN12621000232831
Ethics application status
Approved
Date submitted
14/12/2020
Date registered
4/03/2021
Date last updated
4/03/2021
Date data sharing statement initially provided
4/03/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Coronary artery disease in Aboriginal and Torres Strait Islander people
Scientific title
Prevalence of coronary artery disease in Aboriginal and Torres Strait Islander people presenting to the Emergency Department with suspected acute coronary syndrome
Secondary ID [1] 301918 0
Emergency Medicine Foundation (EMF) Grant application
EMPJ-221R31-2019-STARMER
Universal Trial Number (UTN)
U1111-1256-4137
Trial acronym
CAD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary artery disease 318467 0
Acute Coronary Syndrome 320525 0
Chest Pain 320526 0
Condition category
Condition code
Cardiovascular 316469 316469 0 0
Coronary heart disease
Public Health 316470 316470 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This research project seeks to determine the rate of coronary artery disease (CAD) for adult Aboriginal and Torres Strait Islander people who present to an Emeregency Department (ED) with symptoms of suspected acute coronary syndrome (ACS). This study will utilise coronary artery imaging investigations to measure the proportion of patients with significant CAD. All participants will receive imaging as part of or in addition to standard investigations for suspected ACS. Participants will be followed up after seven days and two months to identify the rate of subsequent major cardiac events (MACE) following the initial presentation to the ED. The research nurse will follow up participants by telephone interview. If the research participant cannot be contacted by telephone, then the research nurse will contact the participant's nominated health service provider with a copy of a consent to release information form to identify whether the participant has had any subsequent cardiac related visits to the health service provider following discharge from hospital.
Intervention code [1] 318223 0
Early Detection / Screening
Intervention code [2] 318462 0
Diagnosis / Prognosis
Comparator / control treatment
Outcomes for participants with and without a diagnosis of ACS will be compared.
Control group
Active

Outcomes
Primary outcome [1] 324626 0
The primary outcome will be the proportion of patients diagnosed with significant coronary artery disease as determined by coronary anatomic characterisation on CTCA imaging and/or invasive coronary angiography (ICA). Significant CAD is defined as =/>50% stenosis in one or more coronary vessels determined by either CTCA or ICA.
Timepoint [1] 324626 0
On initial presentation.
Secondary outcome [1] 385244 0
The proportion of patients diagnosed with acute coronary syndrome as per Cardiology Adjudication of clinical case.
Timepoint [1] 385244 0
At initial presentation.
Secondary outcome [2] 385245 0
The proportion of patients who are current smokers determined by patient interview or medical record.
Timepoint [2] 385245 0
At initial presentation.
Secondary outcome [3] 385246 0
Proportion of patients diagnosed with significant coronary artery disease assessed by coronary anatomic characterisation on CTCA with abnormal EST determined by cardiologist adjudication. .

Timepoint [3] 385246 0
At initial presentation.
Secondary outcome [4] 385247 0
A cumulative composite endpoint of MACE (AMI, cardiac death, urgent/emergency revascularisation). This outcome will be assessed by follow up telephone interview with patients, follow up with patients nominated health provider and review of patient medical records. This outcome will be determined by cardiologist adjudication.
Timepoint [4] 385247 0
On presentation, then at 7 days and two months post initial presentation.
Secondary outcome [5] 385248 0
Subsequent cardiac re-presentation to hospital at two months following initial presentation for suspected ACS. This outcome will be assessed by follow up telephone interview with patients, follow up with patients nominated health provider and review of patient medical records.
Timepoint [5] 385248 0
On presentation, then at 7 days and two months post initial presentation.
Secondary outcome [6] 385249 0
Cost of healthcare utilisation determined by consultation with health economist secondary to data collected for index hospital visit and subsequent presentations to hospital through chart audit.
Timepoint [6] 385249 0
On presentation, then at 7 days and two months post initial presentation.
Secondary outcome [7] 391314 0
Proportion of patients receiving PCI assessed from patient medical record.
Timepoint [7] 391314 0
On presentation, then at 7 days and two months post initial presentation.
Secondary outcome [8] 391315 0
Proportion of patients receiving CABG determined by medical record review and patient follow up telephone interview.
Timepoint [8] 391315 0
On presentation, then at 7 days and two months post initial presentation.
Secondary outcome [9] 392475 0
Proportion of patients with hypertension assessed by patient interview and/or medical record.
Timepoint [9] 392475 0
At initial presentation
Secondary outcome [10] 392477 0
The proportion of patients with hypercholestraemia as determined by patient interview or review of medical record.
Timepoint [10] 392477 0
At initial presentation
Secondary outcome [11] 392480 0
Proportion of patients with Diabetes based on patient interview and/or medical record.
Timepoint [11] 392480 0
At initial presentation
Secondary outcome [12] 392481 0
Proportion of patients with kidney disease based on patient interview and/or medical record
Timepoint [12] 392481 0
At initial presentation
Secondary outcome [13] 392482 0
The proportion of patients that have a family history of coronary artery disease based on patient interview and/or medical record.
Timepoint [13] 392482 0
At initial presentation

Eligibility
Key inclusion criteria
Patients will be included it they:
1. Are aged 18 years and above;
2. Identify as Aboriginal and/or Torres Strait Islander; and
3. Present with symptoms of 5 minutes or more in duration consistent with possible ACS
such as chest discomfort or angina equivalent; and/or; emergency physician plans 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 or lactating;
2. They are less than 18 years of age;
3. The researcher feels that recruitment is inappropriate (e.g. Terminal illness);
4. They (or legal representative) are unable or unwilling to provide informed consent;
5. They (or legal representative) refuse to be followed-up by telephone or medical record
review after 7 days, or they are unlikely to be contactable e.g. they will be overseas;
6. They have a clear alternative non-ACS diagnostic cause for symptoms;
7. They have a know allergy or contraindication to iodinated contrast precluding CTCA/ICA;
8. They have a known allergy or contraindication to beta-blockade medication precluding
CTCA/ICA;
9. They have severe or restrictive airways disease or acute exacerbation precluding
CTCA/ICA;
10. They have significant renal impairment precluding CTCA/ICA; or
11. They have been recruited to this research project within the last 12 months.









Study design
Purpose
Screening
Duration
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Results will be presented according to the STROBE statement. The proportion of patients with CAD will be provided with 95% confidence intervals. The proportion of patients with traditional risk factors for CAD (smoking, diabetes, hypercholesterolemia, hypertension and family history of IDH) will be reported for patients with and without CAD. Differences between CAD and non-CAD patients will be calculated with 95% confidence intervals of the difference. Similarly, descriptive statistics for CAD and non-CAD patients, differences between the groups, and 95% confidence intervals of the difference will be calculated for the following secondary endpoints;
1) Index admission PCI and CABG;
2) EST results;
3) Coronary artery calcium scores;
3) Other cardiac investigations;
4) Incidence of MACE (AMI, cardiac death, urgent/emergency revascularisation) within
two months of presentation;
5) Subsequent cardiac representation to hospital at two months following initial presentation
for suspect ACS.

Logistic regression analysis (or penalized logistic regression) analyses may also be performed to identify predicators of CAD and of ACS in the cohort. Selection of variable for inclusion in the model will be based on the elements in the existing assessment pathway, relevant literature and clinical judgement.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
15/02/2021
Date of last participant enrolment
Anticipated
30/07/2021
Actual
Date of last data collection
Anticipated
30/09/2021
Actual
Sample size
Target
80
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 17186 0
Cairns Base Hospital - Cairns
Recruitment postcode(s) [1] 30890 0
4870 - Cairns

Funding & Sponsors
Funding source category [1] 306331 0
Charities/Societies/Foundations
Name [1] 306331 0
Emergency Medicine Foundation
Country [1] 306331 0
Australia
Funding source category [2] 306350 0
Charities/Societies/Foundations
Name [2] 306350 0
Far North Queensland Hospital Foundation
Country [2] 306350 0
Australia
Primary sponsor type
Individual
Name
Dr Katrina Starmer
Address
Emergency Department
Cairns Hospital,
Esplanade, Cairns North
Country
Australia
Secondary sponsor category [1] 308430 0
None
Name [1] 308430 0
Address [1] 308430 0
Country [1] 308430 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306542 0
Far North Queensland Health Research and Ethics Committe
Ethics committee address [1] 306542 0
Level 7
William McCormack Place 2
5B Sheridan Street
Cairns
Queensland
4870
Ethics committee country [1] 306542 0
Australia
Date submitted for ethics approval [1] 306542 0
12/04/2019
Approval date [1] 306542 0
26/08/2019
Ethics approval number [1] 306542 0

Summary
Brief summary
Aboriginal and Torres Strait Islander people die from acute coronary syndrome (ACS), the life-threatening manifestation of ischaemic heart disease, at younger ages than non-indigenous Australians. The reason for this is unknown, as are the risk factors for ACS in Aboriginal and Torres Strait Islander people. This lack of knowledge limits the usefulness of emergency department (ED) risk assessments for Indigenous patients with suspected ACS, which have been developed using data from a general population and are not specific for Aboriginal and Torres Strait Islander people, despite evidence of clear differences in risk for coronary artery disease (CAD) (the underlying cause of ACS) based on ethnic background in no- Aboriginal and Torres Strait Islander cohorts (African-American, Hispanic, Caucasian, Asian). Chest pain risk assessment allows for rapid diagnosis and treatment of ACS and prevention of over-investigation in patients deemed to be "low-risk". In the absence of evidence, current guidelines recommend a cautions approach and consider Aboriginal and Torres Strait Islander patients with chest pain at higher risk of ACS than non-indigenous patients. We will conduct a prospective, cross-sectional study of Aboriginal and Torres Strait Islander people who present to the Cairns Hospital Emergency Department with chest pain. The primary aim is to determine the rate of CAD, measured by coronary artery imaging. Eligible patients will be asked to consent to provide access to their clinical data for the duration of the study. Participants will receive usual clinical care in the ED and be classified as either "high-risk" or 'not high risk". All "not high-risk" participants will undergo an exercise stress test as part of usual care, followed by coronary artery imaging. All patients will be followed-up after two months to record the subsequent occurrence of cardiac death, acute myocardial infraction, urgent/emergency revascularisation, and cardiac re-presentation to the ED and primary care physicians. The cost of health care utilisation over the two months follow-up will also be determined. Participants will be classified as having clinically significant coronary artery disease (>50% stenosis in at least one coronary artery) or not, and as having ACS or not. Demographic and clinical characteristics will be compared between patient groups. We will recruit 80 patients, which will allow us to measure and expected rate of coronary artery disease of 6.3% with 3% precision. The expected findings from this study will 1) allow ED doctors to determine a baseline level of risk of ACS for Aboriginal and Torres Strait Islander patients who present with chest pain, and 2) provide preliminary information necessary for the design of large- scale research studies with the goal of determining specific risk factors and determine optimum investigative strategies for ACS in Aboriginal and Torres Strait Islander people.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104226 0
Dr Katrina Starmer
Address 104226 0
C/O Department of Emergency Department
Cairns Hospital
165 The Esplanade
Cairns
Queensland
4870
Country 104226 0
Australia
Phone 104226 0
+61 414721488
Fax 104226 0
Email 104226 0
[email protected]
Contact person for public queries
Name 104227 0
Dr Katrina Starmer
Address 104227 0
C/O Department of Emergency Department
Cairns Hospital
165 The Esplanade
Cairns
Queensland
4870
Country 104227 0
Australia
Phone 104227 0
+61 414721488
Fax 104227 0
Email 104227 0
[email protected]
Contact person for scientific queries
Name 104228 0
Prof Louise Cullen
Address 104228 0
C/O Department of Emergency Medicine
Royal Brisbane and Women's Hospital
Butterfield Street & Bowen Bridge road
Herston,
Queensland
4008
Country 104228 0
Australia
Phone 104228 0
+61 7 36468153
Fax 104228 0
Email 104228 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8683Ethical approval  [email protected] 380292-(Uploaded-03-08-2020-18-53-34)-Study-related document.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.