Air Verses Oxygen In myocarDial Infarction Study

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.

Conditions

• Acute Myocardial Infarction
• Coronary Artery Disease

Interventions

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

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%.

Sponsors & Collaborators

• Ambulance Victoria

  collaborator OTHER_GOV

• Monash University

  collaborator OTHER

• Baker Heart and Diabetes Institute

  collaborator OTHER

• FALCK Foundation

  collaborator UNKNOWN

• Bayside Health

  lead OTHER_GOV

Principal Investigators

• Stephen Bernard, MBBS MD · Alfred Hospital, Monash University, Ambulance Victoria

• Karen Smith, BSc PhD · Ambulance Victoria, Monash University

• Dion Stub, MBBS · Alfred Hospital, Baker IDI Institute, Monash University

• Ian Meredith, BSc MBBS PhD · Southern Health, Monash University

• Michael Stephenson, RN BA · Ambulance Victoria

• Janet Bray, RN PhD · Ambulance Victoria

• Bill Barger, ADHS · Ambulance Victoria

• David Kaye, MBBS PhD · Alfred Hospital, Baker IDI Institute, Monash University

• Peter Cameron, MBBS MD · Alfred Hospital, Monash University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-10-31

Primary Completion

2014-01-31

Completion

2014-08-31

Countries

• Australia

Study Locations