Supplemental Oxygen in Catheterized Coronary Emergency Reperfusion
SOCCER
1 other identifier
interventional
100
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2012
Longer than P75 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2011
CompletedFirst Posted
Study publicly available on registry
August 26, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedAugust 31, 2016
February 1, 2016
4.1 years
August 25, 2011
August 30, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Myocardial salvage index
Assessed by cardiac magnetic resonance imaging
Day 4-6 after the acute PCI
Secondary Outcomes (14)
Pain difference
At randomization vs at PCI balloon inflation start
Area at risk
Day 4-6 after the acute PCI
Infarct size
Day 4-6 after the acute PCI
Ejection fraction
Day 4-6 after the acute PCI
Microvascular obstruction
Day 4-6 after the acute PCI
- +9 more secondary outcomes
Study Arms (2)
10 L O2/min
EXPERIMENTALOxygen breathing via Oxymask TM
Room air
SHAM COMPARATORRoom air breathing via Oxymask TM
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Previous AMI
- Inability to make decision to participate; dementia and the like
- For CMR: Significant claustrophobia, prostheses or other magnetic material inside the body
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Skanelead
Study Sites (3)
Helsingborg Hospital
Helsingborg, SE251 87, Sweden
SUS Lund
Lund, SE22185, Sweden
SUS Malmö
Malmo, SE20502, Sweden
Related Publications (7)
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.
PMID: 18708420BACKGROUNDBurls 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.
PMID: 21346260BACKGROUNDNicholson 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.
PMID: 15533106BACKGROUNDBeasley 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.
PMID: 17339308BACKGROUNDFarquhar 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.
PMID: 19699859BACKGROUNDMokhtari 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.
PMID: 32070283DERIVEDKhoshnood 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.
PMID: 29436868DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ulf Ekelund, MD PhD
Skåne University Hospital at Lund
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2011
First Posted
August 26, 2011
Study Start
January 1, 2012
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
August 31, 2016
Record last verified: 2016-02