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Air Verses Oxygen In myocarDial Infarction Study (AVOID)

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01272713
Recruitment Status : Unknown
Verified May 2014 by Ms. Rowan Frew, Bayside Health.
Recruitment status was:  Active, not recruiting
First Posted : January 10, 2011
Last Update Posted : May 7, 2014
Sponsor:
Collaborators:
Ambulance Victoria
Monash University
Baker Heart and Diabetes Institute
FALCK Foundation
Information provided by (Responsible Party):
Ms. Rowan Frew, Bayside Health

Study Description
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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.


Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Coronary Artery Disease Other: Oxygen therapy Other: No oxygen therapy Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 638 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial of Oxygen Therapy in Acute Myocardial Infarction (AVOID - Air Verses Oxygen In myocarDial Infarction Study)
Study Start Date : October 2011
Actual Primary Completion Date : January 2014
Estimated Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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: Oxygen therapy
  • Pre-hospital supplemental oxygen administered via Hudson mask at a flow rate of 8L/min
  • In-hospital oxygen as per hospital protocol
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: 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%.


Outcome Measures
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Primary Outcome Measures :
  1. Myocardial Infarct Size [ Time Frame: At 72 hours post infarct ]

    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.


Secondary Outcome Measures :
  1. ST segment resolution [ Time Frame: 1 day post reperfusion ]
  2. TIMI Flow [ Time Frame: At completion of coronary intervention procedure ]
    TIMI - Thrombolysis in Myocardial infarction score

  3. Survival to Hospital Discharge [ Time Frame: Any ]
  4. Major Adverse Cardiac Events (MACE) [ Time Frame: 6 months ]
    Death, recurrent myocardial infarction, and re-hospitalization measured at 6 months

  5. Myocardial Salvage [ Time Frame: 4 days and 6 months ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01272713


Locations
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Australia, Victoria
Peninsula Private Hospital
Frankston, Victoria, Australia, 3199
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Western Hospital
Melbourne, Victoria, Australia, 3011
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3053
St Vincents Hospital
Melbourne, Victoria, Australia, 3065
Austin Hospital
Melbourne, Victoria, Australia, 3084
Ambulance Victoria
Melbourne, Victoria, Australia, 3108
Box Hill Hospital
Melbourne, Victoria, Australia, 3128
Monash Medical Centre
Melbourne, Victoria, Australia, 3168
Frankston Hospital
Melbourne, Victoria, Australia, 3199
Sponsors and Collaborators
Bayside Health
Ambulance Victoria
Monash University
Baker Heart and Diabetes Institute
FALCK Foundation
Investigators
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Principal Investigator: Stephen Bernard, MBBS MD Alfred Hospital, Monash University, Ambulance Victoria
Principal Investigator: Karen Smith, BSc PhD Ambulance Victoria, Monash University
Study Director: Dion Stub, MBBS Alfred Hospital, Baker IDI Institute, Monash University
Study Director: Ian Meredith, BSc MBBS PhD Southern Health, Monash University
Study Director: Michael Stephenson, RN BA Ambulance Victoria
Study Director: Janet Bray, RN PhD Ambulance Victoria
Study Director: Bill Barger, ADHS Ambulance Victoria
Study Director: David Kaye, MBBS PhD Alfred Hospital, Baker IDI Institute, Monash University
Study Director: Peter Cameron, MBBS MD Alfred Hospital, Monash University
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ms. Rowan Frew, A.Professor Stephen Bernard, Bayside Health
ClinicalTrials.gov Identifier: NCT01272713    
Other Study ID Numbers: HREC/10/ALFRED/52
First Posted: January 10, 2011    Key Record Dates
Last Update Posted: May 7, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Coronary Disease
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases