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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
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Scientific title
A Randomised Controlled Trial of Oxygen Therapy in Acute Myocardial Infarction (AVOID - Air Verses Oxygen In myocarDial Infarction Study)
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Secondary ID [1]
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HREC/10/ALFRED/52
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Universal Trial Number (UTN)
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Trial acronym
AVOID
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Myocardial Infarction
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Coronary Artery Disease
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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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%.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Myocardial Infarct Size
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Assessment method [1]
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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.
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Timepoint [1]
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At 72 hours post infarct
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Secondary outcome [1]
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ST segment resolution
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Assessment method [1]
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Timepoint [1]
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1 day post reperfusion
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Secondary outcome [2]
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TIMI Flow
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Assessment method [2]
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TIMI - Thrombolysis in Myocardial infarction score
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Timepoint [2]
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At completion of coronary intervention procedure
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Secondary outcome [3]
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Survival to Hospital Discharge
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Assessment method [3]
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Timepoint [3]
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Any
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Secondary outcome [4]
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Major Adverse Cardiac Events (MACE)
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Assessment method [4]
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Death, recurrent myocardial infarction, and re-hospitalization measured at 6 months
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Timepoint [4]
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6 months
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Secondary outcome [5]
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Myocardial Salvage
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Assessment method [5]
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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.
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Timepoint [5]
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4 days and 6 months
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/08/2014
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Actual
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Sample size
Target
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Accrual to date
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Final
638
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Peninsula Private Hospital - Frankston
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Recruitment hospital [2]
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Alfred Hospital - Melbourne
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Recruitment hospital [3]
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Western Hospital - Melbourne
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Recruitment hospital [4]
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Royal Melbourne Hospital - Melbourne
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Recruitment hospital [5]
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St Vincents Hospital - Melbourne
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Recruitment hospital [6]
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Austin Hospital - Melbourne
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Recruitment hospital [7]
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Ambulance Victoria - Melbourne
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Recruitment hospital [8]
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Box Hill Hospital - Melbourne
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Recruitment hospital [9]
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Monash Medical Centre - Melbourne
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Recruitment hospital [10]
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Frankston Hospital - Melbourne
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Recruitment postcode(s) [1]
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3199 - Frankston
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Recruitment postcode(s) [2]
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3004 - Melbourne
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Recruitment postcode(s) [3]
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3011 - Melbourne
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Recruitment postcode(s) [4]
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3053 - Melbourne
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Recruitment postcode(s) [5]
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3065 - Melbourne
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Recruitment postcode(s) [6]
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3084 - Melbourne
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Recruitment postcode(s) [7]
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3108 - Melbourne
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Recruitment postcode(s) [8]
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3128 - Melbourne
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Recruitment postcode(s) [9]
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3168 - Melbourne
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Recruitment postcode(s) [10]
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3199 - Melbourne
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Funding & Sponsors
Primary sponsor type
Government body
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Name
Bayside Health
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Address
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Country
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Other collaborator category [1]
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Government body
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Name [1]
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Ambulance Victoria
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Monash University
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Address [2]
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Other collaborator category [3]
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Other
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Name [3]
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Baker Heart and Diabetes Institute
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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FALCK Foundation
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Address [4]
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Country [4]
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Ethics approval
Ethics application status
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Summary
Brief summary
- Aim The AVOID (Air Verses Oxygen In myocardial infarction) trial is designed to determine if the withholding of routine oxygen therapy in patients with acute heart attack leads to reduced heart damage compared to the current practice of routine inhaled oxygen for all patients. - Background There is evidence supporting and refuting the current practice of providing oxygen to all patients with acute heart attack. A recent summary of clinical trials suggested that oxygen may increase the degree of heart damage during heart attack. It also highlighted that the few trials into oxygen therapy were performed before the use of modern medications and procedures to treat heart attack and that further studies were urgently needed, using contemporary practices. - Design A total of 334 patients will participate in this randomized controlled trial. Patients in this study will receive the best current management and care for their condition. Patients will be randomized to routine pre-hospital care with oxygen therapy vs pre-hospital care without oxygen therapy. Patients will then receive standard hospital care, aside from allocated oxygen or no oxygen therapy. The primary outcome measure of heart damage will be investigated using routine blood tests. With additional information gathered from other aspects of routine heart care including coronary angiogram, electrocardiograms and complications of hospital stay. Patients will be followed up at 6 months to determine any longer term effects of treatment.
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Trial website
https://clinicaltrials.gov/study/NCT01272713
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Trial related presentations / publications
Stub D, Smith K, Bernard S, Bray JE, Stephenson M, Cameron P, Meredith I, Kaye DM; AVOID Study. A randomized controlled trial of oxygen therapy in acute myocardial infarction Air Verses Oxygen In myocarDial infarction study (AVOID Study). Am Heart J. 2012 Mar;163(3):339-345.e1. doi: 10.1016/j.ahj.2011.11.011. Stub D, Smith K, Bernard S, Nehme Z, Stephenson M, Bray JE, Cameron P, Barger B, Ellims AH, Taylor AJ, Meredith IT, Kaye DM; AVOID Investigators. Air Versus Oxygen in ST-Segment-Elevation Myocardial Infarction. Circulation. 2015 Jun 16;131(24):2143-50. doi: 10.1161/CIRCULATIONAHA.114.014494. Epub 2015 May 22.
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Public notes
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Contacts
Principal investigator
Name
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Stephen Bernard, MBBS MD
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Address
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Alfred Hospital, Monash University, Ambulance Victoria
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Email
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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
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