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The aim of SOCCER is to evaluate the effects of treatment with supplemental O2 before and during acute balloon angioplasty (PCI) for patients with ST-elevation myocardial infarction (STEMI). One hundred STEMI patients are randomized in the ambulance to either standard O2 treatment (10 l/min) or no supplemental O2, to be given until the end of the acute PCI. Cardiac magnetic resonance imaging and echocardiography during the hospital stay is used to assess infarct size and myocardial performance. All patients are followed for 6 months. At 6 months, perceived health and NT-proBNP are recorded for all patients, and an additional echocardiography is performed. The primary endpoint is the fraction of myocardium saved with the acute PCI. The secondary endpoints include the pain difference between inclusion time and start of PCI and myocardial performance on echocardiography.
Almost all patients with ST elevation myocardial infarction (STEMI) in Sweden undergo acute balloon angioplasty (PCI) to open the occluded coronary artery, and thereby to reduce or abolish the myocardial infarction. Standard treatment in these cases is 10-15 l of supplemental oxygen to reduce the myocardial ischemia and the infarct size. It is, however, unknown whether supplemental O2 is beneficial or detrimental to patients with STEMI undergoing PCI.
This study aims to evaluate the effects of treatment with supplemental O2 in acute PCI for STEMI.
The study is a multicenter single blind parallel group randomized trial. One hundred normoxic STEMI ambulance patients accepted for primary PCI are randomized in the ambulance to either standard O2 treatment (10 l/min) or no supplemental O2, to be given until the end of the acute PCI. All patients undergo cardiac MRI at day 4-6 to determine area at risk, infarct size and myocardial salvage index. Fifty patients undergo an extended echocardiography during the hospital stay to assess infarct size and wall motion score index. All patients are followed for 6 months. At 6 months, perceived health (EQ-5D) and NT-proBNP are recorded for all patients, and an additional echocardiography is performed for the subgroup of 50 patients. The primary endpoint is myocardial salvage index. Secondary endpoints include pain difference between inclusion time and start of PCI and wall motion score index on echocardiography.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10 L O2/min | Experimental | Oxygen breathing via Oxymask TM |
|
| Room air | Sham Comparator | Room air breathing via Oxymask TM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxygen | Drug | Fitting of Oxymask TM and treatment with 10 L O2/min |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial salvage index | Assessed by cardiac magnetic resonance imaging | Day 4-6 after the acute PCI |
| Measure | Description | Time Frame |
|---|---|---|
| Pain difference | Visual analog scale | At randomization vs at PCI balloon inflation start |
| Area at risk | Assessed by cardiac magnetic resonance imaging |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ulf Ekelund, MD PhD | Skåne University Hospital at Lund | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsingborg Hospital | Helsingborg | SE251 87 | Sweden | |||
| SUS Lund |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18708420 | Background | Wijesinghe M, Perrin K, Ranchord A, Simmonds M, Weatherall M, Beasley R. Routine use of oxygen in the treatment of myocardial infarction: systematic review. Heart. 2009 Mar;95(3):198-202. doi: 10.1136/hrt.2008.148742. Epub 2008 Aug 15. | |
| 21346260 | Background | Burls A, Cabello JB, Emparanza JI, Bayliss S, Quinn T. Oxygen therapy for acute myocardial infarction: a systematic review and meta-analysis. Emerg Med J. 2011 Nov;28(11):917-23. doi: 10.1136/emj.2010.103564. Epub 2011 Feb 23. |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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Not provided
| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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| Room air |
| Device |
Fitting of Oxymask TM |
|
| Day 4-6 after the acute PCI |
| Infarct size | Assessed by cardiac magnetic resonance imaging | Day 4-6 after the acute PCI |
| Ejection fraction | Assessed by cardiac magnetic resonance imaging | Day 4-6 after the acute PCI |
| Microvascular obstruction | Assessed by cardiac magnetic resonance imaging | Day 4-6 after the acute PCI |
| Doses of opioids (substance and mg) and betablockers (substance and mg) | Given before and during the PCI |
| Blood oxygen saturation change | Measured by pulse oximeter | From inclusion to PCI start |
| Infarct size | Measured with area under TnT curve | First 24 h after inclusion |
| ST segment recovery | As measured on ECG | 90 minutes after acute PCI |
| TIMI flow | Measured with coronary angiography | During acute PCI |
| Use of heart failure medications (beta blockers, ACEI, ARB, diuretics, digoxin and sinus node inhibitors etc) | At 6 months |
| Perceived health | Measured with EQ-5D | At 6 months |
| Wall motion score index on echocardiography | Measured on echocardiography | Day 2-3 after acute PCI |
| Change in wall motion score index | Measured on echocardiography | From index hospitalization to 6 months |
| Lund |
| SE22185 |
| Sweden |
| SUS Malmö | Malmö | SE20502 | Sweden |
| 15533106 | Background | Nicholson C. A systematic review of the effectiveness of oxygen in reducing acute myocardial ischaemia. J Clin Nurs. 2004 Nov;13(8):996-1007. doi: 10.1111/j.1365-2702.2004.00997.x. |
| 17339308 | Background | Beasley R, Aldington S, Weatherall M, Robinson G, McHaffie D. Oxygen therapy in myocardial infarction: an historical perspective. J R Soc Med. 2007 Mar;100(3):130-3. doi: 10.1177/014107680710000311. No abstract available. |
| 19699859 | Background | Farquhar H, Weatherall M, Wijesinghe M, Perrin K, Ranchord A, Simmonds M, Beasley R. Systematic review of studies of the effect of hyperoxia on coronary blood flow. Am Heart J. 2009 Sep;158(3):371-7. doi: 10.1016/j.ahj.2009.05.037. Epub 2009 Jul 15. |
| 32070283 | Derived | Mokhtari A, Akbarzadeh M, Sparv D, Bhiladvala P, Arheden H, Erlinge D, Khoshnood A. Oxygen therapy in patients with ST elevation myocardial infarction based on the culprit vessel: results from the randomized controlled SOCCER trial. BMC Emerg Med. 2020 Feb 18;20(1):12. doi: 10.1186/s12873-020-00309-y. |
| 29436868 | Derived | Khoshnood A, Akbarzadeh M, Carlsson M, Sparv D, Bhiladvala P, Mokhtari A, Erlinge D, Ekelund U. Effect of oxygen therapy on chest pain in patients with ST elevation myocardial infarction: results from the randomized SOCCER trial. Scand Cardiovasc J. 2018 Apr;52(2):69-73. doi: 10.1080/14017431.2018.1439183. Epub 2018 Feb 13. |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |