Supplemental Oxygen in Catheterized Coronary Emergency Reperfusion
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Region Skane
- Enrollment
- 100
- Locations
- 3
- Primary Endpoint
- Myocardial salvage index
Study Overview
Brief Summary
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
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
10 L O2/min
Oxygen breathing via Oxymask TM
Intervention: Oxygen (Drug)
Room air
Room air breathing via Oxymask TM
Intervention: Room air (Device)
Outcomes
Primary Outcomes
Myocardial salvage index
Time Frame: Day 4-6 after the acute PCI
Assessed by cardiac magnetic resonance imaging
Secondary Outcomes
- Ejection fraction(Day 4-6 after the acute PCI)
- Blood oxygen saturation change(From inclusion to PCI start)
- ST segment recovery(90 minutes after acute PCI)
- Use of heart failure medications (beta blockers, ACEI, ARB, diuretics, digoxin and sinus node inhibitors etc)(At 6 months)
- Wall motion score index on echocardiography(Day 2-3 after acute PCI)
- Area at risk(Day 4-6 after the acute PCI)
- Microvascular obstruction(Day 4-6 after the acute PCI)
- TIMI flow(During acute PCI)
- Perceived health(At 6 months)
- Doses of opioids (substance and mg) and betablockers (substance and mg)(Given before and during the PCI)
- Pain difference(At randomization vs at PCI balloon inflation start)
- Infarct size(First 24 h after inclusion)
- Change in wall motion score index(From index hospitalization to 6 months)