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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
Helsingborg Hospital
Helsingborg, Sweden
SUS Lund
Lund, Sweden
SUS Malmö
Malmö, Sweden
Myocardial salvage index
Assessed by cardiac magnetic resonance imaging
Time frame: Day 4-6 after the acute PCI
Pain difference
Visual analog scale
Time frame: At randomization vs at PCI balloon inflation start
Area at risk
Assessed by cardiac magnetic resonance imaging
Time frame: Day 4-6 after the acute PCI
Infarct size
Assessed by cardiac magnetic resonance imaging
Time frame: Day 4-6 after the acute PCI
Ejection fraction
Assessed by cardiac magnetic resonance imaging
Time frame: Day 4-6 after the acute PCI
Microvascular obstruction
Assessed by cardiac magnetic resonance imaging
Time frame: Day 4-6 after the acute PCI
Doses of opioids (substance and mg) and betablockers (substance and mg)
Time frame: Given before and during the PCI
Blood oxygen saturation change
Measured by pulse oximeter
Time frame: From inclusion to PCI start
Infarct size
Measured with area under TnT curve
Time frame: First 24 h after inclusion
ST segment recovery
As measured on ECG
Time frame: 90 minutes after acute PCI
TIMI flow
Measured with coronary angiography
Time frame: During acute PCI
Use of heart failure medications (beta blockers, ACEI, ARB, diuretics, digoxin and sinus node inhibitors etc)
Time frame: At 6 months
Perceived health
Measured with EQ-5D
Time frame: At 6 months
Wall motion score index on echocardiography
Measured on echocardiography
Time frame: Day 2-3 after acute PCI
Change in wall motion score index
Measured on echocardiography
Time frame: From index hospitalization to 6 months
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