Air Verses Oxygen In myocarDial Infarction Study

NCT01272713 | Unknown DMC

• 1 other identifier: HREC/10/ALFRED/52
• Study Type: interventional
• Target: 638
• Locations: 1 country
• Sites: 10

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.

Conditions

Acute Myocardial Infarction; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  At 72 hours post infarct

Secondary Outcomes (5)

• ST segment resolution

  1 day post reperfusion

• TIMI Flow

  At completion of coronary intervention procedure

• Survival to Hospital Discharge

  Any

• Major Adverse Cardiac Events (MACE)

  6 months

• Myocardial Salvage

  4 days and 6 months

Study Arms (2)

Oxygen therapy

OTHER

* 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

No oxygen therapy

OTHER

* 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

Interventions

Oxygen therapy OTHER

* Pre-hospital supplemental oxygen administered via Hudson mask at a flow rate of 8L/min * In-hospital oxygen as per hospital protocol

Oxygen therapy

No oxygen therapy OTHER

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%.

No oxygen therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Hypoxia with oxygen saturation measured on pulse oximeter \< 94% with the patient breathing air
• Bronchospasm requiring nebulised salbutamol therapy using oxygen
• Altered conscious state

Sponsors & Collaborators

• Bayside Health: lead
• Ambulance Victoria: collaborator
• Monash University: collaborator
• Baker Heart and Diabetes Institute: collaborator
• FALCK Foundation: collaborator

Study Sites (10)

Peninsula Private Hospital

Frankston, Victoria, 3199, Australia

Location

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Western Hospital

Melbourne, Victoria, 3011, Australia

Location

Royal Melbourne Hospital

Melbourne, Victoria, 3053, Australia

Location

St Vincents Hospital

Melbourne, Victoria, 3065, Australia

Location

Austin Hospital

Melbourne, Victoria, 3084, Australia

Location

Ambulance Victoria

Melbourne, Victoria, 3108, Australia

Location

Box Hill Hospital

Melbourne, Victoria, 3128, Australia

Location

Monash Medical Centre

Melbourne, Victoria, 3168, Australia

Location

Frankston Hospital

Melbourne, Victoria, 3199, Australia

Location

Related Publications (2)

• 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.

  PMID: 22424003 BACKGROUND

• Stub D, Smith K, Bernard S, Nehme Z, Stephenson M, Bray JE, Cameron P, Barger B, Ellims AH, Taylor AJ, Meredith IT, Kaye DM; AVOID Investigators. Air Versus Oxygen in ST-Segment-Elevation Myocardial Infarction. Circulation. 2015 Jun 16;131(24):2143-50. doi: 10.1161/CIRCULATIONAHA.114.014494. Epub 2015 May 22.

  PMID: 26002889 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Stephen Bernard, MBBS MD

  Alfred Hospital, Monash University, Ambulance Victoria

  PRINCIPAL INVESTIGATOR

• Karen Smith, BSc PhD

  Ambulance Victoria, Monash University

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: A.Professor Stephen Bernard

Study Record Dates

• First Submitted: December 22, 2010
• First Posted: January 10, 2011
• Study Start: October 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: August 1, 2014
• Last Updated: May 7, 2014

Record last verified: 2014-05

Locations

AU (10)