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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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 - 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
Timepoint [1] 0 0
1 day post reperfusion
Secondary outcome [2] 0 0
TIMI Flow - 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
Timepoint [3] 0 0
Any
Secondary outcome [4] 0 0
Major Adverse Cardiac Events (MACE) - Death, recurrent myocardial infarction, and re-hospitalization measured at 6 months
Timepoint [4] 0 0
6 months
Secondary outcome [5] 0 0
Myocardial Salvage - 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
Gender
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 status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Other
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Ambulance Victoria
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Monash University
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Baker Heart and Diabetes Institute
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
FALCK Foundation
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT01272713
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.
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
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01272713