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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01272713




Registration number
NCT01272713
Ethics application status
Date submitted
22/12/2010
Date registered
10/01/2011
Date last updated
7/05/2014

Titles & IDs
Public title
Air Verses Oxygen In myocarDial Infarction Study
Scientific title
A Randomised Controlled Trial of Oxygen Therapy in Acute Myocardial Infarction (AVOID - Air Verses Oxygen In myocarDial Infarction Study)
Secondary ID [1] 0 0
HREC/10/ALFRED/52
Universal Trial Number (UTN)
Trial acronym
AVOID
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myocardial Infarction 0 0
Coronary Artery Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Oxygen therapy
Other interventions - No oxygen therapy

Other: Oxygen therapy - * Standard acute coronary syndrome treatment as per hospital protocol
* Pre-hospital supplemental oxygen administered via Hudson mask at a flow rate of 8L/min
* In-hospital oxygen as per hospital protocol

Other: No oxygen therapy - * Standard acute coronary syndrome treatment as per hospital protocol
* No oxygen pre-hospital or in-hospital unless the oxygen saturation falls below 94% in which case oxygen will be administered via nasal cannulae (4L/min) or Hudson mask (8L/min) and titrated to achieve oxygen saturation of 94%.


Other interventions: Oxygen therapy
* Pre-hospital supplemental oxygen administered via Hudson mask at a flow rate of 8L/min
* In-hospital oxygen as per hospital protocol

Other interventions: No oxygen therapy
No oxygen pre-hospital or in-hospital unless the oxygen saturation falls below 94% in which case oxygen will be administered via nasal cannulae (4L/min) or Hudson mask (8L/min) and titrated to achieve oxygen saturation of 94%.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Myocardial Infarct Size
Assessment method [1] 0 0
The primary end-point for the study will be infarct size at hospital discharge which will be ascertained by the routinely collected cardiac biomarkers during hospital admission such as cardiac troponin I (cTnI) and creatine kinase (CK)Infarct size will be evaluated via blood test on admission and then 6 hourly tests for 48 hours and 12 hourly measurements between 48 hours and 72 hours. Infarct size will be measured by: * Mean and peak cTnI * Mean and peak CK * The area under the curve of CK and cTnI release over the first 72 hours of reperfusion.
Timepoint [1] 0 0
At 72 hours post infarct
Secondary outcome [1] 0 0
ST segment resolution
Assessment method [1] 0 0
Timepoint [1] 0 0
1 day post reperfusion
Secondary outcome [2] 0 0
TIMI Flow
Assessment method [2] 0 0
TIMI - Thrombolysis in Myocardial infarction score
Timepoint [2] 0 0
At completion of coronary intervention procedure
Secondary outcome [3] 0 0
Survival to Hospital Discharge
Assessment method [3] 0 0
Timepoint [3] 0 0
Any
Secondary outcome [4] 0 0
Major Adverse Cardiac Events (MACE)
Assessment method [4] 0 0
Death, recurrent myocardial infarction, and re-hospitalization measured at 6 months
Timepoint [4] 0 0
6 months
Secondary outcome [5] 0 0
Myocardial Salvage
Assessment method [5] 0 0
Magnetic resonance imaging (MRI) measurement of infarct size as percent of area at risk determined with T2-weighted MRI (in small sub set of patients) at day 4 and repeated at 6 months.
Timepoint [5] 0 0
4 days and 6 months

Eligibility
Key inclusion criteria
* Adults = 18 years of age.
* Chest pain for < 12 hours
* ST-elevation Myocardial Infarction including either: 1) Persistent ST-segment elevation of =1mm in two contiguous limb leads; 2) ST-segment elevation of = 2mm in two contiguous chest leads, or; 3) New left bundle branch block (LBBB) pattern.
* Able to be transported to a participating hospital
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Hypoxia with oxygen saturation measured on pulse oximeter < 94% with the patient breathing air
* Bronchospasm requiring nebulised salbutamol therapy using oxygen
* Altered conscious state

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2014
Actual
Sample size
Target
Accrual to date
Final
638
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peninsula Private Hospital - Frankston
Recruitment hospital [2] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [3] 0 0
Western Hospital - Melbourne
Recruitment hospital [4] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [5] 0 0
St Vincents Hospital - Melbourne
Recruitment hospital [6] 0 0
Austin Hospital - Melbourne
Recruitment hospital [7] 0 0
Ambulance Victoria - Melbourne
Recruitment hospital [8] 0 0
Box Hill Hospital - Melbourne
Recruitment hospital [9] 0 0
Monash Medical Centre - Melbourne
Recruitment hospital [10] 0 0
Frankston Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3199 - Frankston
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
3011 - Melbourne
Recruitment postcode(s) [4] 0 0
3053 - Melbourne
Recruitment postcode(s) [5] 0 0
3065 - Melbourne
Recruitment postcode(s) [6] 0 0
3084 - Melbourne
Recruitment postcode(s) [7] 0 0
3108 - Melbourne
Recruitment postcode(s) [8] 0 0
3128 - Melbourne
Recruitment postcode(s) [9] 0 0
3168 - Melbourne
Recruitment postcode(s) [10] 0 0
3199 - Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Bayside Health
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Ambulance Victoria
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Monash University
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Baker Heart and Diabetes Institute
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
FALCK Foundation
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephen Bernard, MBBS MD
Address 0 0
Alfred Hospital, Monash University, Ambulance Victoria
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01272713