Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000500459
Ethics application status
Approved
Date submitted
14/09/2007
Date registered
28/09/2007
Date last updated
29/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Oxygen Protocols for The treatment of Myocardial Infarction: Mortality, Infarct Size & Efficacy
Scientific title
A randomised controlled trial to compare the efficacy of high flow versus titrated oxygen therapy in the management of ST-segment elevation Myocardial Infarction
Universal Trial Number (UTN)
Trial acronym
OPTIMISE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myocardial Infarction 2232 0
Condition category
Condition code
Cardiovascular 2324 2324 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Variable flow oxygen (titrated to achieve an oxygen saturation of 93-96%; administered via nasal prongs or medium concentration mask as required).
Intervention code [1] 1677 0
Treatment: Other
Comparator / control treatment
Continuous high flow oxygen (6L/min via medium concentration mask).
Control group
Active

Outcomes
Primary outcome [1] 3220 0
Mortality
Timepoint [1] 3220 0
30-day (assessed at day 30 based on data from the previous 30-days)
Secondary outcome [1] 5369 0
Major adverse cardiac events (MACE)
Timepoint [1] 5369 0
30-Day (assessed at day 30 based on data from the previous 30-days)
Secondary outcome [2] 5370 0
Infarct size measured by Troponin T
Timepoint [2] 5370 0
72-hours after randomisation
Secondary outcome [3] 5371 0
Infarct size measured by Magnetic Resonance Imaging (MRI)
Timepoint [3] 5371 0
4-6 weeks post-discharge
Secondary outcome [4] 5372 0
Brain Natriuretic Peptide (BNP) level
Timepoint [4] 5372 0
24 hours after randomisation
Secondary outcome [5] 5373 0
Left ventricular ejection fraction measured by MRI
Timepoint [5] 5373 0
4-6 weeks post-discharge
Secondary outcome [6] 5374 0
In-hospital mortality as a combined analysis with data from the only other RCT of oxygen therapy in myocardial infarction
Timepoint [6] 5374 0
In-hospital (assessed at the time of hospital discharge)

Eligibility
Key inclusion criteria
Present with ST-segment elevation myocardial infarction (STEMI) based on established diagnostic criteria
Are at least 18 years of age and competent to provide written informed consent before entering the study. Informed consent must be signed by the study participant.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe Chronic Obstructive Pulmonary Disease (COPD) or other respiratory disease with PaCO2 > 45mm Hg;
Previous myocardial infarction;
Subjects who are not to be admitted to the coronary care unit;
Women who are known to be pregnant;
Cardiogenic shock at the time of presentation at hospital;
Severe arterial hypoxaemia (oxygen saturation less than/equal to 85%) at time of presentation;
Patients enrolled in other cardiology studies.; patients who have had previous treatment with bleomycin.

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)
Subjects that consent and meet study criteria will be enrolled in to the study and allocated a treatment by the allocation of a sealed randomisation envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Third party randomisation will be used with random number sequences generated by a computer programme.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
17/07/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 502 0
United Kingdom
State/province [1] 502 0
Greater Manchester
Country [2] 503 0
New Zealand
State/province [2] 503 0
Wellington

Funding & Sponsors
Funding source category [1] 2575 0
Charities/Societies/Foundations
Name [1] 2575 0
The Cardiology Research Trust
Country [1] 2575 0
New Zealand
Funding source category [2] 2576 0
Charities/Societies/Foundations
Name [2] 2576 0
Capital Cardiovascular Research Trust
Country [2] 2576 0
New Zealand
Funding source category [3] 2577 0
Hospital
Name [3] 2577 0
Capital & Coast District Health Board
Country [3] 2577 0
New Zealand
Funding source category [4] 2609 0
Charities/Societies/Foundations
Name [4] 2609 0
Moulton Charitable Foundation
Country [4] 2609 0
United Kingdom
Primary sponsor type
Charities/Societies/Foundations
Name
Medical Research Institute of New Zealand
Address
PO Box 10055
The Terrace
Wellington
Country
New Zealand
Secondary sponsor category [1] 2333 0
Hospital
Name [1] 2333 0
University Hospital of South Manchester NHS Foundation Trust
Address [1] 2333 0
Southmoor Road
Wythenshawe
Manchester
M23 9LT
Country [1] 2333 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4494 0
Central Regional Ethics Committee
Ethics committee address [1] 4494 0
PO Box 5013
Wellington
Ethics committee country [1] 4494 0
New Zealand
Date submitted for ethics approval [1] 4494 0
30/10/2006
Approval date [1] 4494 0
28/02/2007
Ethics approval number [1] 4494 0
CEN/06/11/103
Ethics committee name [2] 4529 0
South Manchester Research Ethics Committee
Ethics committee address [2] 4529 0
Room 181 Gateway House
Piccadilly South
Manchester
M60 7LP
Ethics committee country [2] 4529 0
United Kingdom
Date submitted for ethics approval [2] 4529 0
10/05/2007
Approval date [2] 4529 0
13/07/2007
Ethics approval number [2] 4529 0
07/Q1403/100

Summary
Brief summary
There is increasing evidence to suggest that the routine use of high flow oxygen in the treatment of patients with myocardial infarction (heart attack) may be harmful. It seems likely that administration of oxygen at a level titrated (adjusted) to meet the oxygen needs of an individual patient may result in fewer adverse effects and improved patient outcomes than treatment with the standard high flow approach. This trial will randomly allocate patients presenting at the coronary care unit with a type of heart attack called a STEMI (ST segment elevation myocardial infarction) to either high flow or titrated oxygen therapy. The oxygen will be administered for 6 hours. The effects of the different treatments will be determined by taking blood tests whilst the patient is in-hospital to look at levels of proteins called Troponin T and BNP. The levels of these proteins act as indicators of the extent of damage that has happened in the heart. The study will also look at patients survival rates and their overall cardiovascular well-being in hospital and for 30-days after their myocardial infarction and at approximately 4-6 weeks after discharge from hospital patients will have an MRI scan which can be used to determine the extent of damage to the heart.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27780 0
Address 27780 0
Country 27780 0
Phone 27780 0
Fax 27780 0
Email 27780 0
Contact person for public queries
Name 10866 0
Dr Anil Ranchord
Address 10866 0
Wellington Hospital
Private Bag 7902
Wellington South
Country 10866 0
New Zealand
Phone 10866 0
+64 4 385 5999
Fax 10866 0
+64 4 385 5856
Email 10866 0
[email protected]
Contact person for scientific queries
Name 1794 0
Dr Mark Simmonds
Address 1794 0
Wellington Hospital
Private Bag 7902
Wellington South
Country 1794 0
New Zealand
Phone 1794 0
+64 4 385 5999
Fax 1794 0
+64 4 385 5856
Email 1794 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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