None listed
Conditions
Brief summary
There is increasing evidence to suggest that the routine use of high flow oxygen in the treatment of patients with myocardial infarction (heart attack) may be harmful. It seems likely that administration of oxygen at a level titrated (adjusted) to meet the oxygen needs of an individual patient may result in fewer adverse effects and improved patient outcomes than treatment with the standard high flow approach. This trial will randomly allocate patients presenting at the coronary care unit with a type of heart attack called a STEMI (ST segment elevation myocardial infarction) to either high flow or titrated oxygen therapy. The oxygen will be administered for 6 hours. The effects of the different treatments will be determined by taking blood tests whilst the patient is in-hospital to look at levels of proteins called Troponin T and BNP. The levels of these proteins act as indicators of the extent of damage that has happened in the heart. The study will also look at patients survival rates and their overall cardiovascular well-being in hospital and for 30-days after their myocardial infarction and at approximately 4-6 weeks after discharge from hospital patients will have an MRI scan which can be used to determine the extent of damage to the heart.
Interventions
Variable flow oxygen (titrated to achieve an oxygen saturation of 93-96%; administered via nasal prongs or medium concentration mask as required).
Sponsors
Medical Research Institute of New Zealand
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to -2147483648 No limit
Healthy volunteers
No
Inclusion criteria
Present with ST-segment elevation myocardial infarction (STEMI) based on established diagnostic criteria Are at least 18 years of age and competent to provide written informed consent before entering the study. Informed consent must be signed by the study participant.
Exclusion criteria
Severe Chronic Obstructive Pulmonary Disease (COPD) or other respiratory disease with PaCO2 > 45mm Hg; Previous myocardial infarction; Subjects who are not to be admitted to the coronary care unit; Women who are known to be pregnant; Cardiogenic shock at the time of presentation at hospital; Severe arterial hypoxaemia (oxygen saturation less than/equal to 85%) at time of presentation; Patients enrolled in other cardiology studies.; patients who have had previous treatment with bleomycin.
Outcome results
None listed