drugset / Trial / NCT01423929

Supplemental Oxygen in Catheterized Coronary Emergency Reperfusion

NCT01423929

Phase 4 Completed 100 enrolled Region Skane
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2012-01
Primary completion
2016-02
Completion
2016-02

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Oxygen Other / unclassified 10 unknown Other