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Air Verses Oxygen In myocarDial Infarction Study (AVOID)

This study is currently recruiting participants.
Verified October 2011 by Bayside Health
Sponsor:
Collaborators:
Ambulance Victoria
Monash University
Baker IDI Heart and Diabetes Institute
FALCK Foundation
Information provided by (Responsible Party):
Ms. Rowan Frew, Bayside Health
ClinicalTrials.gov Identifier:
NCT01272713
First received: December 22, 2010
Last updated: October 19, 2011
Last verified: October 2011
History of Changes
  Purpose

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 Intervention
Acute Myocardial Infarction
Coronary Artery Disease
Oxygen
 Other: Withholding oxygen in uncomplicated patients with STEMI
Other: Oxygen

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayside Health:

Primary Outcome Measures:
  • Myocardial infarct size [ Time Frame: At 72 hours post infarct ] [ Designated as safety issue: No ]

    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:
  • ST segment resolution [ Time Frame: 60 minutes post reperfusion ] [ Designated as safety issue: No ]
  • TIMI Flow [ Time Frame: At completion of coronary intervention procedure ] [ Designated as safety issue: No ]
    TIMI - Thrombolysis in Myocardial infarction score

  • Survival to hospital discharge [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
  • MACE [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Major Adverse Cardiac Events (MACE): Death, MI, re-hospitalization measured at 6 months

  • myocardial salvage [ Time Frame: 4 days and 6 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 490
Study Start Date: October 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No oxygen

For patients randomised to Oxygen Therapy:

  • Standard acute coronary syndrome treatment as per hospital protocol
  • Pre-hospital supplemental oxygen administered via Hudson mask at 8/l min
  • In-hospital oxygen as per hospital protocol
 Other: Withholding oxygen in uncomplicated patients with STEMI
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%
Oxygen therapy

For patients allocated to No Oxygen:

  • 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: Oxygen
Oxygen administered via Hudson mask at 8/l min

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults ≥18 years of age.
  • Chest pain for <12 hours
  • ST-elevation Myocardial Infarction including either:
  • Persistent ST-segment elevation of ≥1mm in two contiguous limb leads
  • ST-segment elevation of ≥2mm in two contiguous chest leads
  • New left bundle branch block (LBBB) pattern.

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
  • Patient requests transport to non-study hospital
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01272713

Contacts
Contact: Dion Stub, MBBS 613 9076 3171 d.stub@alfred.org.au
Contact: Stephen Bernard, MBBS MD s.bernard@alfred.org.au

Locations
Australia, Victoria
Ambulance Victoria Recruiting
Melbourne, Victoria, Australia, 3108
Principal Investigator: Karen Smith, BSc PhD            
Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Principal Investigator: Anthony Dart, BA BM BCh DPhil            
Austin Hospital Not yet recruiting
Melbourne, Victoria, Australia, 3084
Principal Investigator: Omar Farouque, MBBS PhD            
Box Hill Hospital Recruiting
Melbourne, Victoria, Australia, 3128
Principal Investigator: Gishel New, MBBS PhD            
Cabrini Hospital Not yet recruiting
Melbourne, Victoria, Australia, 3144
Principal Investigator: Jeffrey Lefkovits, MBBS            
Epworth Hospital Not yet recruiting
Melbourne, Victoria, Australia, 3121
Principal Investigator: Ron Dick, MBBS            
Frankston Hospital Not yet recruiting
Melbourne, Victoria, Australia, 3199
Principal Investigator: Geoffrey Toogoood, MBBS            
Knox Hospital Not yet recruiting
Melbourne, Victoria, Australia, 3152
Principal Investigator: Michael Rowe, MBBS            
Royal Melbourne Hospital Not yet recruiting
Melbourne, Victoria, Australia, 3053
Principal Investigator: Leeanne Grigg, MBBS            
Monash Medical Centre Recruiting
Melbourne, Victoria, Australia, 3168
Principal Investigator: Ian Meredith, BSc MBBS PhD            
Northern Hospital Not yet recruiting
Melbourne, Victoria, Australia, 3076
Principal Investigator: William Van Gaal, MBBS MSc            
Western Hospital Not yet recruiting
Melbourne, Victoria, Australia, 3011
Principal Investigator: Yean Lim, MBBS PhD            
St Vincents Hospital Not yet recruiting
Melbourne, Victoria, Australia, 3065
Principal Investigator: Robert Whitbourn, MBBS BSc MD            
Sponsors and Collaborators
Bayside Health
Ambulance Victoria
Monash University
Baker IDI Heart and Diabetes Institute
FALCK Foundation
Investigators
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 Grad Dip Ambulance Victoria
Study Director: Janet Bray, RN PhD Ambulance Victoria
Study Director: Bill Barger, ADHS Ambulance Victoria
Study Director: Ian Jarvie 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

No publications provided by Bayside Health

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

Responsible Party: Ms. Rowan Frew, A.Professor Stephen Bernard, Bayside Health
ClinicalTrials.gov Identifier: NCT01272713     History of Changes
Other Study ID Numbers: HREC/10/ALFRED/52
Study First Received: December 22, 2010
Last Updated: October 19, 2011
Health Authority: Australia: Human Research Ethics Committee

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Infarction
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
 Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on June 18, 2013