Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12608000005358
Ethics application status
Approved
Date submitted
27/12/2007
Date registered
7/01/2008
Date last updated
29/06/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Angina and High Flow Oxygen
Scientific title
A single group interventional trial of the effect of high flow oxygen on angina in patients with coronary disease
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary disease 2435 0
Condition category
Condition code
Cardiovascular 2538 2538 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
High flow oxygen (administered as 15L/min via a non-rebreather mask for 30 minutes)
Intervention code [1] 2157 0
Treatment: Other
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3439 0
First onset of definite angina replicating the subject's normal symptoms.
Timepoint [1] 3439 0
Assessed during the 30 minutes the subject is receiving high flow oxygen.
Secondary outcome [1] 5720 0
New ST segment changes greater than or equal to 1mm or T wave inversion as demonstrated by an electrocardiogram (ECG).
Timepoint [1] 5720 0
Assessed during the 30 minutes the subject is receiving high flow oxygen.
Secondary outcome [2] 6050 0
Need to stop the intervention because of any reason deemed to be of clinical concern by the attending doctor.
Timepoint [2] 6050 0
Assessed during the 30 minutes the subject is receiving high flow oxygen.

Eligibility
Key inclusion criteria
Current inpatients on the cardiac care unit (CCU) Wellington Hospital; confirmed diagnosis of coronary disease on angiography; experiencing chest pain (at rest or with minimal exertion) considered by CCU staff to be consistent with angina.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with chest pain at the time of enrolment; diagnosis of severe Chronic Obstructive Pulmonary Disease (COPD) or emphysema; room air oxygen saturations less than 92%; presence of bundle branch block pattern on resting ECG; patients requiring intravenous nitrates; glyceryl trinitrate use in the previous 2 hours.

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)
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/02/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 619 0
New Zealand
State/province [1] 619 0
Wellington

Funding & Sponsors
Funding source category [1] 2685 0
Charities/Societies/Foundations
Name [1] 2685 0
Medical Research Institute of New Zealand
Country [1] 2685 0
New Zealand
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] 2429 0
None
Name [1] 2429 0
Address [1] 2429 0
Country [1] 2429 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4607 0
Central Regional Ethics Committee
Ethics committee address [1] 4607 0
PO Box 5013
Wellington
Ethics committee country [1] 4607 0
New Zealand
Date submitted for ethics approval [1] 4607 0
18/06/2007
Approval date [1] 4607 0
17/10/2007
Ethics approval number [1] 4607 0
CEN/07/07/044

Summary
Brief summary
It is routine clinical practice to administer high flow oxygen to patients with a heart attack or angina; however, there is some evidence to suggest that this approach may be harmful, especially in patients who are not hypoxic. This single group interventional trial aims to test this by recruiting 50 inpatients from the coronary care unit at Wellington Hospital who have confirmed coronary disease and a history of angina at rest or with minimal exertion. Subjects will receive high flow oxygen for 30 minutes. Subjects will be monitored to establish if angina occurs during the oxygen administration and if so how soon after it starts. ECGs will be taken throughout the study to monitor for any significant changes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28099 0
Address 28099 0
Country 28099 0
Phone 28099 0
Fax 28099 0
Email 28099 0
Contact person for public queries
Name 11256 0
Dr Kyle Perrin
Address 11256 0
Medical Research Institute of NZ
PO Box 10055
The Terrace
Wellington
Country 11256 0
New Zealand
Phone 11256 0
0064 4 472 9120
Fax 11256 0
0064 4 472 9224
Email 11256 0
[email protected]
Contact person for scientific queries
Name 2184 0
Dr Kyle Perrin
Address 2184 0
Medical Research Institute of NZ
PO Box 10055
The Terrace
Wellington
Country 2184 0
New Zealand
Phone 2184 0
0064 4 472 9120
Fax 2184 0
0064 4 472 9224
Email 2184 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.