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Supplemental Oxygen in Catheterized Coronary Emergency Reperfusion

NCT01423929 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2016-08-31

No results posted yet for this study

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.

Conditions

  • ST Elevation Myocardial Infarction

Interventions

DRUG

Oxygen

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

DEVICE

Room air

Fitting of Oxymask TM

Sponsors & Collaborators

  • Region Skane

    lead OTHER

Principal Investigators

  • Ulf Ekelund, MD PhD · Skåne University Hospital at Lund

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01423929 on ClinicalTrials.gov