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Supplemental Oxygen in Catheterized Coronary Emergency Reperfusion (SOCCER)

Primary Purpose

ST Elevation Myocardial Infarction

Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Oxygen
Room air
Sponsored by
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST Elevation Myocardial Infarction focused on measuring Oxygen, Myocardial infarction, Ambulance, Percutaneous coronary intervention, Cardiac magnetic resonance imaging

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Helsingborg Hospital
  • SUS Lund
  • SUS Malmö

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

10 L O2/min

Room air

Arm Description

Oxygen breathing via Oxymask TM

Room air breathing via Oxymask TM

Outcomes

Primary Outcome Measures

Myocardial salvage index
Assessed by cardiac magnetic resonance imaging

Secondary Outcome Measures

Pain difference
Visual analog scale
Area at risk
Assessed by cardiac magnetic resonance imaging
Infarct size
Assessed by cardiac magnetic resonance imaging
Ejection fraction
Assessed by cardiac magnetic resonance imaging
Microvascular obstruction
Assessed by cardiac magnetic resonance imaging
Doses of opioids (substance and mg) and betablockers (substance and mg)
Blood oxygen saturation change
Measured by pulse oximeter
Infarct size
Measured with area under TnT curve
ST segment recovery
As measured on ECG
TIMI flow
Measured with coronary angiography
Use of heart failure medications (beta blockers, ACEI, ARB, diuretics, digoxin and sinus node inhibitors etc)
Perceived health
Measured with EQ-5D
Wall motion score index on echocardiography
Measured on echocardiography
Change in wall motion score index
Measured on echocardiography

Full Information

First Posted
August 25, 2011
Last Updated
August 30, 2016
Sponsor
Region Skane
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1. Study Identification

Unique Protocol Identification Number
NCT01423929
Brief Title
Supplemental Oxygen in Catheterized Coronary Emergency Reperfusion
Acronym
SOCCER
Official Title
Supplemental Oxygen in Catheterized Coronary Emergency Reperfusion
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Skane

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST Elevation Myocardial Infarction
Keywords
Oxygen, Myocardial infarction, Ambulance, Percutaneous coronary intervention, Cardiac magnetic resonance imaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
10 L O2/min
Arm Type
Experimental
Arm Description
Oxygen breathing via Oxymask TM
Arm Title
Room air
Arm Type
Sham Comparator
Arm Description
Room air breathing via Oxymask TM
Intervention Type
Drug
Intervention Name(s)
Oxygen
Intervention Description
Fitting of Oxymask TM and treatment with 10 L O2/min
Intervention Type
Device
Intervention Name(s)
Room air
Intervention Description
Fitting of Oxymask TM
Primary Outcome Measure Information:
Title
Myocardial salvage index
Description
Assessed by cardiac magnetic resonance imaging
Time Frame
Day 4-6 after the acute PCI
Secondary Outcome Measure Information:
Title
Pain difference
Description
Visual analog scale
Time Frame
At randomization vs at PCI balloon inflation start
Title
Area at risk
Description
Assessed by cardiac magnetic resonance imaging
Time Frame
Day 4-6 after the acute PCI
Title
Infarct size
Description
Assessed by cardiac magnetic resonance imaging
Time Frame
Day 4-6 after the acute PCI
Title
Ejection fraction
Description
Assessed by cardiac magnetic resonance imaging
Time Frame
Day 4-6 after the acute PCI
Title
Microvascular obstruction
Description
Assessed by cardiac magnetic resonance imaging
Time Frame
Day 4-6 after the acute PCI
Title
Doses of opioids (substance and mg) and betablockers (substance and mg)
Time Frame
Given before and during the PCI
Title
Blood oxygen saturation change
Description
Measured by pulse oximeter
Time Frame
From inclusion to PCI start
Title
Infarct size
Description
Measured with area under TnT curve
Time Frame
First 24 h after inclusion
Title
ST segment recovery
Description
As measured on ECG
Time Frame
90 minutes after acute PCI
Title
TIMI flow
Description
Measured with coronary angiography
Time Frame
During acute PCI
Title
Use of heart failure medications (beta blockers, ACEI, ARB, diuretics, digoxin and sinus node inhibitors etc)
Time Frame
At 6 months
Title
Perceived health
Description
Measured with EQ-5D
Time Frame
At 6 months
Title
Wall motion score index on echocardiography
Description
Measured on echocardiography
Time Frame
Day 2-3 after acute PCI
Title
Change in wall motion score index
Description
Measured on echocardiography
Time Frame
From index hospitalization to 6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulf Ekelund, MD PhD
Organizational Affiliation
Skåne University Hospital at Lund
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsingborg Hospital
City
Helsingborg
ZIP/Postal Code
SE251 87
Country
Sweden
Facility Name
SUS Lund
City
Lund
ZIP/Postal Code
SE22185
Country
Sweden
Facility Name
SUS Malmö
City
Malmö
ZIP/Postal Code
SE20502
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
18708420
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.
Results Reference
background
PubMed Identifier
21346260
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.
Results Reference
background
PubMed Identifier
15533106
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.
Results Reference
background
PubMed Identifier
17339308
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.
Results Reference
background
PubMed Identifier
19699859
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.
Results Reference
background
PubMed Identifier
32070283
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.
Results Reference
derived
PubMed Identifier
29436868
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.
Results Reference
derived

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Supplemental Oxygen in Catheterized Coronary Emergency Reperfusion

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