Supplemental Oxygen in Catheterized Coronary Emergency Reperfusion

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Supplemental Oxygen in Catheterized Coronary Emergency Reperfusion

Conditions
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ST Elevation Myocardial Infarction

Intervention / Treatment
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* Drug: Oxygen
* Device: Room air


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: STEMI patient transported with ambulance to SUS Lund or Malmö or Helsingborg hospital, and accepted for acute PCI Symptom duration less than 6 hours Normal SaO2 (≥ 94 %) measured with pulse oximeter Informed consent Exclusion Criteria: Previous AMI Inability to make decision to participate; dementia and the like For CMR: Significant claustrophobia, prostheses or other magnetic material inside the body
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 10 L O2/min<br>Oxygen breathing via Oxymask TM | Drug: Oxygen<br>* Fitting of Oxymask TM and treatment with 10 L O2/min<br>|
| Sham Comparator: Room air<br>Room air breathing via Oxymask TM | Device: Room air<br>* Fitting of Oxymask TM<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial salvage index | Assessed by cardiac magnetic resonance imaging | Day 4-6 after the acute PCI | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxygen, Myocardial infarction, Ambulance, Percutaneous coronary intervention, Cardiac magnetic resonance imaging