ST Elevation Myocardial Infarction Clinical Trial
— SOCCEROfficial title:
Supplemental Oxygen in Catheterized Coronary Emergency Reperfusion
Verified date | February 2016 |
Source | Region Skane |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: Medical Products Agency |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | February 2016 |
Est. primary completion date | February 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Sweden | Helsingborg Hospital | Helsingborg | |
Sweden | SUS Lund | Lund | |
Sweden | SUS Malmö | Malmö |
Lead Sponsor | Collaborator |
---|---|
Region Skane |
Sweden,
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. Review. — View 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. Review. — View 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. Review. — View 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. Review. — View 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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Myocardial salvage index | Assessed by cardiac magnetic resonance imaging | Day 4-6 after the acute PCI | No |
Secondary | Pain difference | Visual analog scale | At randomization vs at PCI balloon inflation start | No |
Secondary | Area at risk | Assessed by cardiac magnetic resonance imaging | Day 4-6 after the acute PCI | No |
Secondary | Infarct size | Assessed by cardiac magnetic resonance imaging | Day 4-6 after the acute PCI | No |
Secondary | Ejection fraction | Assessed by cardiac magnetic resonance imaging | Day 4-6 after the acute PCI | No |
Secondary | Microvascular obstruction | Assessed by cardiac magnetic resonance imaging | Day 4-6 after the acute PCI | No |
Secondary | Doses of opioids (substance and mg) and betablockers (substance and mg) | Given before and during the PCI | No | |
Secondary | Blood oxygen saturation change | Measured by pulse oximeter | From inclusion to PCI start | No |
Secondary | Infarct size | Measured with area under TnT curve | First 24 h after inclusion | No |
Secondary | ST segment recovery | As measured on ECG | 90 minutes after acute PCI | No |
Secondary | TIMI flow | Measured with coronary angiography | During acute PCI | No |
Secondary | Use of heart failure medications (beta blockers, ACEI, ARB, diuretics, digoxin and sinus node inhibitors etc) | At 6 months | No | |
Secondary | Perceived health | Measured with EQ-5D | At 6 months | No |
Secondary | Wall motion score index on echocardiography | Measured on echocardiography | Day 2-3 after acute PCI | No |
Secondary | Change in wall motion score index | Measured on echocardiography | From index hospitalization to 6 months | No |
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