Air Verses Oxygen In myocarDial Infarction Study (AVOID)
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|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
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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.
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.
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||638 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
Other: Oxygen therapy
No oxygen therapy
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%.
- 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.
- ST segment resolution [ Time Frame: 1 day post reperfusion ]
- TIMI Flow [ Time Frame: At completion of coronary intervention procedure ]TIMI - Thrombolysis in Myocardial infarction score
- Survival to Hospital Discharge [ Time Frame: Any ]
- Major Adverse Cardiac Events (MACE) [ Time Frame: 6 months ]Death, recurrent myocardial infarction, and re-hospitalization measured at 6 months
- 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- Hypoxia with oxygen saturation measured on pulse oximeter < 94% with the patient breathing air
- Bronchospasm requiring nebulised salbutamol therapy using oxygen
- Altered conscious state
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
|Peninsula Private Hospital|
|Frankston, Victoria, Australia, 3199|
|Melbourne, Victoria, Australia, 3004|
|Melbourne, Victoria, Australia, 3011|
|Royal Melbourne Hospital|
|Melbourne, Victoria, Australia, 3053|
|St Vincents Hospital|
|Melbourne, Victoria, Australia, 3065|
|Melbourne, Victoria, Australia, 3084|
|Melbourne, Victoria, Australia, 3108|
|Box Hill Hospital|
|Melbourne, Victoria, Australia, 3128|
|Monash Medical Centre|
|Melbourne, Victoria, Australia, 3168|
|Melbourne, Victoria, Australia, 3199|
|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|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Ms. Rowan Frew, A.Professor Stephen Bernard, Bayside Health|
|Other Study ID Numbers:||
|First Posted:||January 10, 2011 Key Record Dates|
|Last Update Posted:||May 7, 2014|
|Last Verified:||May 2014|
Coronary Artery Disease
Arterial Occlusive Diseases