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Trial registered on ANZCTR


Registration number
ACTRN12616000461493
Ethics application status
Approved
Date submitted
13/08/2015
Date registered
8/04/2016
Date last updated
8/04/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Oxygen Therapy in Acute Coronary Syndromes Trial
Scientific title
All New Zealand Acute Coronary syndromes quality improvement (ANZACS-QI) registry trial to evaluate two oxygen protocols as part of usual care in patients presenting with a suspected acute coronary syndrome
Secondary ID [1] 287270 0
Nil
Universal Trial Number (UTN)
U1111-1173-1861
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome 295891 0
Condition category
Condition code
Cardiovascular 296143 296143 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention strategies will commence from first medical contact by the ambulance service or in the emergency department.

High oxygen strategy
In patients with probable or confirmed acute coronary syndrome give oxygen for ischemic chest pain, ischemic ECG changes or dyspnea related to myocardial ischemia irrespective of the measured oxygen saturation level.
In the ambulance oxygen will be administered by face mask at ~8l/minute. If a face mask is not tolerated give oxygen by nasal prongs at ~4 l/minute. Oxygen flow rate is increased if necessary to achieve saturation greater than or equal to 95%. Continue oxygen until the patient is admitted to hospital or when a doctor decides it is no longer necessary.
In hospital oxygen can be administered by face mask at between 5 and 8 l/minute or by nasal prongs between 1 and 4 L/minute. Increase or adjust the flow rate to achieve an oxygen saturation between 95% and 99%. The treating clinician will decide on oxygen flow rate, method of administration, and when to discontinue oxygen when symptoms and signs (including ECG changes) of ischemia have resolved, or when clinically appropriate.
Caution or avoid high flow oxygen in patients at risk of hypercapnia, including those with possible obesity hypoventilation syndrome or chronic obstructive pulmonary disease.

In individual cases the oxygen protocol can be overruled by clinician preference or clinical indication.

Two regions will be randomised to use the high oxygen strategy for 4 months, then wash out for two weeks, then use the conservative oyygen strategy for 12 months, then wash-out for two weeks, then use the high oxygen strategy for 8 months.
Intervention code [1] 292570 0
Treatment: Other
Comparator / control treatment
Conservative oxygen strategy
In patients with a suspected or confirmed acute coronary syndrome do not give oxygen for ischemic chest pain, ischemic ECG changes or dyspnea related to myocardial ischemia, unless the measured oxygen saturation is less than 90%.
When the oxygen saturation cannot be measured only administer oxygen if there is a significant clinical concern of hypoxia.
The treating clinician will make the decision on oxygen administration flow rate and whether to use a mask or nasal prongs.
If oxygen is administered by face mask or nasal prongs adjust the flow rate to achieve a target oxygen saturation of 90 to 94%.
The protocol recommends oxygen is discontinued when no longer needed to maintain saturation greater than 90%.
Caution or avoid high flow oxygen in patients with possible obesity hypoventilation syndrome or chronic obstructive pulmonary disease.
Oxygen can be administered in the ambulance to patients who need ventilation or continuous positive airways pressure (CPAP).
In individual cases the oxygen protocol can be overruled by clinician preference or clinical indication.
Two regions will be randomised to use the conservative oxygen strategy for 4 months, then wash out for two weeks, then use the high oyygen strategy for 12 months, then wash-out for two weeks, then use the conservative oxygen strategy for 8 months.
Control group
Active

Outcomes
Primary outcome [1] 295820 0
30 day mortality rate by electronic linkage to national mortality data-base
Timepoint [1] 295820 0
Mortality rate 30 days following episode of ACS
Secondary outcome [1] 316596 0
One year mortality rate
by electronic linkage to national mortality data-base
Timepoint [1] 316596 0
One year following episode of ACS
Secondary outcome [2] 317370 0
Hospital readmission for cardiovascular cause at one year form national hosptial admission data.
Timepoint [2] 317370 0
One year following episode of ACS

Eligibility
Key inclusion criteria
1. All patients in New Zealand admitted to the coronary care unit and/or cardiac catheter laboratory with an acute coronary syndrome (ACS) at participating hospitals.
2. Patients attended by the ambulance service with a confirmed ACS who die before admission to CCU or catheter lab.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Dead on ambulance arrival at the scene
2. Presented with an out of hospital cardiac arrest
3. Ventilated prior to admission to CCU/catheter lab
4. Documented for end of life cares
5. On home oxygen
6. Not admitted to CCU or catheter lab because of advanced age, co-morbidity, or because a diagnosis other than ACS is made. (this does not exclude patient from administered oxygen strategy prior to this decision being made).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The proposed study has a cluster randomized cross over design. The unit of randomization will be the four regional cardiac clinical networks and time periods of 4 months each . One of two oxygen administration protocols will be recommended for use in the ambulance, emergency department, CCU and cardiac catheter lab for all subjects presenting with a proven or suspected ACS. Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Based on a recent report of all patients admitted to NZ hospitals with an ACS 30 day mortality was 9.5%, and one year mortality was 20.6%. With a simple comparison of the two strategies on first admission of all eligible patients over the trial period, a total sample size of ~21,000 would have 80% power at 5% level of significance (two-sided) to detect a 1% difference in 30 day mortality (the primary outcome). The statistical power for differences in mortality of >1% would be stronger. This power calculation does not account for the cluster randomization design (4 networks), which will be considered as a fixed effect in analysis.

Treatment evaluation will be performed on the principle of intention to treat. All patients in the ANZACS-QI registries presenting with an acute coronary syndrome will be included. For patients with multiple admissions during the trial, the oxygen protocol used at the first admission will be applied in the analysis.

Patients’ baseline characteristics will be summarized descriptively for each treatment period and by important subgroups. Mortality rates will be presented as frequency and percentage, and compared between two treatment targets using generalized linear regression models, controlling for the fixed effects of cluster and time period. A similar approach will be applied to other secondary outcomes.

The trial will be monitored by the Health Research Council of New Zealand Data Safety Monitoring Committee

Recruitment
Recruitment status
Not yet 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] 7090 0
New Zealand
State/province [1] 7090 0

Funding & Sponsors
Funding source category [1] 291833 0
Charities/Societies/Foundations
Name [1] 291833 0
National Heart Foundation New Zealand
Address [1] 291833 0
PO Box 17-160 Greenlane, Auckland 1546
Country [1] 291833 0
New Zealand
Primary sponsor type
Individual
Name
Dr Ralph Stewart
Address
Cardiovascular research unit,
Auckland City Hospital,
Park Rd. Grafton, Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 290500 0
None
Name [1] 290500 0
Address [1] 290500 0
Country [1] 290500 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293349 0
Health and Disability Ethics Committee
Ethics committee address [1] 293349 0
Ministry of Health
Freyburg Building
20 Aitken Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 293349 0
New Zealand
Date submitted for ethics approval [1] 293349 0
17/08/2015
Approval date [1] 293349 0
15/09/2015
Ethics approval number [1] 293349 0
15/NTA/117

Summary
Brief summary
Oxygen has been routinely administered as part of the standard of care to patients presenting with acute myocardial infarction for many years. However, several reviews of the limited experimental and clinical evidence have questioned its’ benefits and risks. The NZ national cardiac clinical network trials group will compare two oxygen protocols as part of usual care in the ambulance, emergency department, coronary care unit and cardiac catheter laboratory. The proposed study is a ~2 year randomized cross-over study within the 4 regional cardiac networks. The primary outcome will be 30 day mortality.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59502 0
Dr Ralph Stewart
Address 59502 0
Green Lane Cardiovascular Service,
Auckland City Hospital,
Private Bag 92024,
Auckland 1030
Country 59502 0
New Zealand
Phone 59502 0
+64 9 3074949 ext 23668
Fax 59502 0
Email 59502 0
rstewart@adhb.govt.nz
Contact person for public queries
Name 59503 0
Dr Ralph Stewart
Address 59503 0
Green Lane Cardiovascular Service,
Auckland City Hospital,
Private Bag 92024,
Auckland 1030
Country 59503 0
New Zealand
Phone 59503 0
+64 9 3074949 ext 23668
Fax 59503 0
Email 59503 0
rstewart@adhb.govt.nz
Contact person for scientific queries
Name 59504 0
Dr Ralph Stewart
Address 59504 0
Green Lane Cardiovascular Service,
Auckland City Hospital,
Private Bag 92024,
Auckland 1030
Country 59504 0
New Zealand
Phone 59504 0
+64 9 3074949 ext 23668
Fax 59504 0
Email 59504 0
rstewart@adhb.govt.nz

No information has been provided regarding IPD availability
Summary results
No Results