Clinical trial NCT01423929: Supplemental Oxygen in Catheterized Coronary Emergency Reperfusion
Official title: Supplemental Oxygen in Catheterized Coronary Emergency Reperfusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: ST Elevation Myocardial Infarction
Keywords: Oxygen
Myocardial infarction
Ambulance
Percutaneous coronary intervention
Cardiac magnetic resonance imaging
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2011-08-26
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Myocardial salvage index
timeFrame: Day 4-6 after the acute PCI
Secondary outcomes:
measure: Pain difference
timeFrame: At randomization vs at PCI balloon inflation start
measure: Area at risk
timeFrame: Day 4-6 after the acute PCI
measure: Infarct size
timeFrame: Day 4-6 after the acute PCI
measure: Ejection fraction
timeFrame: Day 4-6 after the acute PCI
measure: Microvascular obstruction
timeFrame: Day 4-6 after the acute PCI
measure: Doses of opioids (substance and mg) and betablockers (substance and mg)
timeFrame: Given before and during the PCI
measure: Blood oxygen saturation change
timeFrame: From inclusion to PCI start
measure: Infarct size
timeFrame: First 24 h after inclusion
measure: ST segment recovery
timeFrame: 90 minutes after acute PCI
measure: TIMI flow
timeFrame: During acute PCI
measure: Use of heart failure medications (beta blockers, ACEI, ARB, diuretics, digoxin and sinus node inhibitors etc)
timeFrame: At 6 months
measure: Perceived health
timeFrame: At 6 months
measure: Wall motion score index on echocardiography
timeFrame: Day 2-3 after acute PCI
measure: Change in wall motion score index
timeFrame: From index hospitalization to 6 months
Other outcomes:
Locations:
city: Helsingborg
country: Sweden
facility: Helsingborg Hospital
city: Lund
country: Sweden
facility: SUS Lund
city: Malmö
country: Sweden
facility: SUS Malmö
Study officials:
affiliation: Skåne University Hospital at Lund
name: Ulf Ekelund, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.