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NCT Number: NCT01423929

Supplemental Oxygen in Catheterized Coronary Emergency Reperfusion

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Helsingborg Hospital, Helsingborg, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxygen

Drug

Fitting of Oxymask TM and treatment with 10 L O2/min

room air

Device

Fitting of Oxymask TM

Primary outcomes

  1. Myocardial salvage index

    Time frame: Day 4-6 after the acute PCI

    Assessed by cardiac magnetic resonance imaging

Secondary outcomes

  1. Pain difference

    Time frame: At randomization vs at PCI balloon inflation start

    Visual analog scale

  2. Area at risk

    Time frame: Day 4-6 after the acute PCI

    Assessed by cardiac magnetic resonance imaging

  3. Infarct size

    Time frame: Day 4-6 after the acute PCI

    Assessed by cardiac magnetic resonance imaging

  4. Ejection fraction

    Time frame: Day 4-6 after the acute PCI

    Assessed by cardiac magnetic resonance imaging

  5. Microvascular obstruction

    Time frame: Day 4-6 after the acute PCI

    Assessed by cardiac magnetic resonance imaging

  6. Doses of opioids (substance and mg) and betablockers (substance and mg)

    Time frame: Given before and during the PCI

  7. Blood oxygen saturation change

    Time frame: From inclusion to PCI start

    Measured by pulse oximeter

  8. Infarct size

    Time frame: First 24 h after inclusion

    Measured with area under TnT curve

  9. ST segment recovery

    Time frame: 90 minutes after acute PCI

    As measured on ECG

  10. TIMI flow

    Time frame: During acute PCI

    Measured with coronary angiography

  11. Use of heart failure medications (beta blockers, ACEI, ARB, diuretics, digoxin and sinus node inhibitors etc)

    Time frame: At 6 months

  12. Perceived health

    Time frame: At 6 months

    Measured with EQ-5D

  13. Wall motion score index on echocardiography

    Time frame: Day 2-3 after acute PCI

    Measured on echocardiography

  14. Change in wall motion score index

    Time frame: From index hospitalization to 6 months

    Measured on echocardiography

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Acronym: SOCCER

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Aug 26, 2011
Registry last updated
Aug 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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