Supplemental Oxygen in Catheterized Coronary Emergency Reperfusion

ST Elevation Myocardial Infarction Clinical Trial

— SOCCER  

Official title:

Supplemental Oxygen in Catheterized Coronary Emergency Reperfusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01423929
• Other study ID #: 2011-001452-11
• Status: Completed
• Phase: Phase 4
• First received: August 25, 2011
• Last updated: August 30, 2016
• Start date: January 2012
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Emergencies
• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

Drug:
• Oxygen
Fitting of Oxymask TM and treatment with 10 L O2/min

Device:
• Room air
Fitting of Oxymask TM

Locations

Country	Name	City	State
Sweden	Helsingborg Hospital	Helsingborg
Sweden	SUS Lund	Lund
Sweden	SUS Malmö	Malmö

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

References & Publications (5)

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

Outcome

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