Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000202460
Ethics application status
Approved
Date submitted
3/04/2007
Date registered
12/04/2007
Date last updated
14/09/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Oxygen therapy and myocardial ischaemia during exercise testing
Scientific title
A double blind randomised controlled cross-over trial of the effect of high flow oxygen on myocardial ischaemia during exercise treadmill testing (ETT)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myocardial ischaemia 1727 0
Condition category
Condition code
Cardiovascular 1818 1818 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will receive two oxygen regimes in a cross over fashion: room air (placebo) for 5 minutes before the start and continued until the end of the ETT, and high flow oxygen (15/L minute) (comparator) via a non-rebreather mask for 5 minutes before the start and continued until the end of the ETT. The order that the regimes are received will be allocated randomly and there will be approximately 90 minutes between tests. Exercise will be standardised according to the Bruce protocol for exercise stress tests. The ETT will be stopped for any of the following reasons

ST elevation, LBBB or arrhythmia occurs
The patient requests to stop the test
The development of diagnostic ECG ischaemia for 15 seconds
The cardiology registrar determines that the ETT should be stopped


If none of these endpoints are reached then the duration of the ETT will be determined by the exercise capacity of the patient.
Intervention code [1] 1676 0
Treatment: Other
Comparator / control treatment
Room air (placebo) for 5 minutes before the start and continued until the end of the ETT
Control group
Placebo

Outcomes
Primary outcome [1] 2549 0
Time to onset of chest pain and inducible ischaemia
Timepoint [1] 2549 0
Monitored continuously as per normal ETT.
Secondary outcome [1] 4391 0
Magnitude of ST depression at peak exercise. The ST segment represents the period from the end of ventricular depolarization to the beginning of ventricular repolarization.
Timepoint [1] 4391 0
Measured at the end of ETT.
Secondary outcome [2] 4392 0
Number of leads showing ST depression.
Timepoint [2] 4392 0
Measured at the end of ETT.
Secondary outcome [3] 4393 0
Blood pressure and heart rate changes.
Timepoint [3] 4393 0
Measured every 3 minutes as per standard ETT.

Eligibility
Key inclusion criteria
Inducible ischaemia on ETT with chest pain.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Abnormal resting electrocardiogram (ECG)ST-elevation during the ETTGlobal ischaemia during the ETT suggesting a possible left main stem lesionArrythmia during the ETTUnstable angina (daily episodes at rest)Left bundle branch block developing during the ETTCongestive heart failureSevere hypertension (systolic >200mmHg)Chronic obstructive respiratory disease or other respiratory disease with oxygen saturations measured at <92% on room airPatients who do not develop chest pain despite evidence of inducible ischaemiaUnstable gaitPatients with contraindication to aspirin, metoprolol or simvastatin.

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 into the study and allocated treatment by accessing a randomisation list at a central administration site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated list of randomised subject assignments will be used
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
An unblinded staff member will administer the treatment. The assessor(s) and data analyst(s) will be blinded.
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/04/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 501 0
New Zealand
State/province [1] 501 0

Funding & Sponsors
Funding source category [1] 1970 0
Government body
Name [1] 1970 0
Capital and Coast District Health Board
Country [1] 1970 0
New Zealand
Primary sponsor type
Individual
Name
Dr Mark Simmonds
Address
Wellington Hospital
Private Bag 7902
Wellington
Country
New Zealand
Secondary sponsor category [1] 1781 0
Government body
Name [1] 1781 0
Capital and Coast District Health Board
Address [1] 1781 0
Private Bag 7902
Wellington
Country [1] 1781 0
New Zealand
Secondary sponsor category [2] 1782 0
Charities/Societies/Foundations
Name [2] 1782 0
Wellington Cardiology Research Trust
Address [2] 1782 0
Wellington Hospital
Private Bag 7902
Wellington
Country [2] 1782 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3665 0
Central Regional Ethics Committee
Ethics committee address [1] 3665 0
PO Bpx 5013
Wellington
Ethics committee country [1] 3665 0
New Zealand
Date submitted for ethics approval [1] 3665 0
Approval date [1] 3665 0
28/02/2007
Ethics approval number [1] 3665 0
CEN/06/11/102

Summary
Brief summary
It is routine clinical practice to administer high flow oxygen to all patients with a heart attack. However, there is evidence to suggest that this approach may be harmful, particularly to those patients who are not hypoxic. High flow oxygen causing hyperoxia has been shown to increase blood pressure and reduce cardiac output, and possibly also reduce coronary artery blood flow. As a result it is crucial that the effects of high flow oxygen on myocardial ischaemia is investigated further in patients with ischaemic heart disease. A double-blind randomised controlled cross-over trial using exercise treadmill testing is an ideal method to measure the effect of supplementary oxygen on myocardial ischaemia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27779 0
Address 27779 0
Country 27779 0
Phone 27779 0
Fax 27779 0
Email 27779 0
Contact person for public queries
Name 10865 0
Dr Anil Ranchord
Address 10865 0
Cardiology Department
Wellington Hospital
Private Bag 7902
Wellington
Country 10865 0
New Zealand
Phone 10865 0
+64 4 385 5999
Fax 10865 0
+64 4 385 5856
Email 10865 0
Anil.Ranchord@ccdhb.org.nz
Contact person for scientific queries
Name 1793 0
Dr Mark Simmonds
Address 1793 0
Cardiology Department
Wellington Hospital
Private Bag 7902
Wellington
Country 1793 0
New Zealand
Phone 1793 0
+64 4 385 5999
Fax 1793 0
+64 4 385 5856
Email 1793 0
Mark.Simmonds@ccdhb.org.nz

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

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