Supplemental Oxygen in Catheterized Coronary Emergency Reperfusion (SOCCER)

August 30, 2016 updated by: Region Skane
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Helsingborg, Sweden, SE251 87
        • Helsingborg Hospital
      • Lund, Sweden, SE22185
        • SUS Lund
      • Malmö, Sweden, SE20502
        • SUS Malmö

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 10 L O2/min
Oxygen breathing via Oxymask TM
Drug: Oxygen
Fitting of Oxymask TM and treatment with 10 L O2/min
Sham Comparator: Room air
Room air breathing via Oxymask TM
Device: Room air
Fitting of Oxymask TM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myocardial salvage index
Time Frame: Day 4-6 after the acute PCI
Assessed by cardiac magnetic resonance imaging
Day 4-6 after the acute PCI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain difference
Time Frame: At randomization vs at PCI balloon inflation start
Visual analog scale
At randomization vs at PCI balloon inflation start
Area at risk
Time Frame: Day 4-6 after the acute PCI
Assessed by cardiac magnetic resonance imaging
Day 4-6 after the acute PCI
Infarct size
Time Frame: Day 4-6 after the acute PCI
Assessed by cardiac magnetic resonance imaging
Day 4-6 after the acute PCI
Ejection fraction
Time Frame: Day 4-6 after the acute PCI
Assessed by cardiac magnetic resonance imaging
Day 4-6 after the acute PCI
Microvascular obstruction
Time Frame: Day 4-6 after the acute PCI
Assessed by cardiac magnetic resonance imaging
Day 4-6 after the acute PCI
Doses of opioids (substance and mg) and betablockers (substance and mg)
Time Frame: Given before and during the PCI
Given before and during the PCI
Blood oxygen saturation change
Time Frame: From inclusion to PCI start
Measured by pulse oximeter
From inclusion to PCI start
Infarct size
Time Frame: First 24 h after inclusion
Measured with area under TnT curve
First 24 h after inclusion
ST segment recovery
Time Frame: 90 minutes after acute PCI
As measured on ECG
90 minutes after acute PCI
TIMI flow
Time Frame: During acute PCI
Measured with coronary angiography
During acute PCI
Use of heart failure medications (beta blockers, ACEI, ARB, diuretics, digoxin and sinus node inhibitors etc)
Time Frame: At 6 months
At 6 months
Perceived health
Time Frame: At 6 months
Measured with EQ-5D
At 6 months
Wall motion score index on echocardiography
Time Frame: Day 2-3 after acute PCI
Measured on echocardiography
Day 2-3 after acute PCI
Change in wall motion score index
Time Frame: From index hospitalization to 6 months
Measured on echocardiography
From index hospitalization to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Skane

Investigators

  • Principal Investigator: Ulf Ekelund, MD PhD, Skåne University Hospital at Lund

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

August 25, 2011

First Submitted That Met QC Criteria

August 25, 2011

First Posted (Estimate)

August 26, 2011

Study Record Updates

Last Update Posted (Estimate)

August 31, 2016

Last Update Submitted That Met QC Criteria

August 30, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-001452-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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