Supplemental Oxygen in Catheterized Coronary Emergency Reperfusion (SOCCER)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Region Skane
Sponsor:
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT01423929
First received: August 25, 2011
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
ST Elevation Myocardial Infarction
Drug: Oxygen
Device: Room air
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Supplemental Oxygen in Catheterized Coronary Emergency Reperfusion

Resource links provided by NLM:


Further study details as provided by Region Skane:

Primary Outcome Measures:
  • Myocardial salvage index [ Time Frame: Day 4-6 after the acute PCI ] [ Designated as safety issue: No ]
    Assessed by cardiac magnetic resonance imaging


Secondary Outcome Measures:
  • Pain difference [ Time Frame: At randomization vs at PCI balloon inflation start ] [ Designated as safety issue: No ]
    Visual analog scale

  • Area at risk [ Time Frame: Day 4-6 after the acute PCI ] [ Designated as safety issue: No ]
    Assessed by cardiac magnetic resonance imaging

  • Infarct size [ Time Frame: Day 4-6 after the acute PCI ] [ Designated as safety issue: No ]
    Assessed by cardiac magnetic resonance imaging

  • Ejection fraction [ Time Frame: Day 4-6 after the acute PCI ] [ Designated as safety issue: No ]
    Assessed by cardiac magnetic resonance imaging

  • Microvascular obstruction [ Time Frame: Day 4-6 after the acute PCI ] [ Designated as safety issue: No ]
    Assessed by cardiac magnetic resonance imaging

  • Doses of opioids (substance and mg) and betablockers (substance and mg) [ Time Frame: Given before and during the PCI ] [ Designated as safety issue: No ]
  • Blood oxygen saturation change [ Time Frame: From inclusion to PCI start ] [ Designated as safety issue: No ]
    Measured by pulse oximeter

  • Infarct size [ Time Frame: First 24 h after inclusion ] [ Designated as safety issue: No ]
    Measured with area under TnT curve

  • ST segment recovery [ Time Frame: 90 minutes after acute PCI ] [ Designated as safety issue: No ]
    As measured on ECG

  • TIMI flow [ Time Frame: During acute PCI ] [ Designated as safety issue: No ]
    Measured with coronary angiography

  • Use of heart failure medications (beta blockers, ACEI, ARB, diuretics, digoxin and sinus node inhibitors etc) [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
  • Perceived health [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
    Measured with EQ-5D

  • Wall motion score index on echocardiography [ Time Frame: Day 2-3 after acute PCI ] [ Designated as safety issue: No ]
    Measured on echocardiography

  • Change in wall motion score index [ Time Frame: From index hospitalization to 6 months ] [ Designated as safety issue: No ]
    Measured on echocardiography


Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01423929

Contacts
Contact: Mahin Akbarzadeh, MSc, RN +46 46 176781

Locations
Sweden
Helsingborg Hospital Not yet recruiting
Helsingborg, Sweden, SE251 87
Contact: Sven-Erik Olsson, MD       sven-erik.olsson@skane.se   
SUS Lund Recruiting
Lund, Sweden, SE22185
Contact: Ardavan Khoshnood, MD       ardavan.khoshnood@gmail.com   
SUS Malmö Recruiting
Malmö, Sweden, SE20502
Contact: Patrik Tydén, MD       patrik.tyden@med.lu.se   
Sponsors and Collaborators
Region Skane
Investigators
Principal Investigator: Ulf Ekelund, MD PhD Skåne University Hospital at Lund
  More Information

Publications:
Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT01423929     History of Changes
Other Study ID Numbers: 2011-001452-11
Study First Received: August 25, 2011
Last Updated: January 20, 2014
Health Authority: Sweden: Medical Products Agency

Keywords provided by Region Skane:
Oxygen
Myocardial infarction
Ambulance
Percutaneous coronary intervention
Cardiac magnetic resonance imaging

Additional relevant MeSH terms:
Emergencies
Infarction
Myocardial Infarction
Disease Attributes
Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 20, 2014