Air Verses Oxygen In myocarDial Infarction Study (AVOID)

This study is ongoing, but not recruiting participants.
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: May 6, 2014
Last verified: May 2014
  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
Other: Oxygen therapy
Other: No oxygen therapy

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:


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: 1 day 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: Any ] [ Designated as safety issue: No ]
  • Major Adverse Cardiac Events (MACE) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Death, recurrent myocardial infarction, and 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.


Enrollment: 638
Study Start Date: October 2011
Estimated Study Completion Date: August 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%.

  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: 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01272713

Locations
Australia, Victoria
Peninsula Private Hospital
Frankston, Victoria, Australia, 3199
Box Hill Hospital
Melbourne, Victoria, Australia, 3128
Austin Hospital
Melbourne, Victoria, Australia, 3084
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3053
Frankston Hospital
Melbourne, Victoria, Australia, 3199
Ambulance Victoria
Melbourne, Victoria, Australia, 3108
Monash Medical Centre
Melbourne, Victoria, Australia, 3168
Western Hospital
Melbourne, Victoria, Australia, 3011
St Vincents Hospital
Melbourne, Victoria, Australia, 3065
Alfred Hospital
Melbourne, Victoria, Australia, 3004
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 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

Publications:
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: May 6, 2014
Health Authority: Australia: Human Research Ethics Committee

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

ClinicalTrials.gov processed this record on September 30, 2014