CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 100 enrolled
Drug / intervention
Oxygen +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01423929
NCT01423929Phase 4Completed

Supplemental Oxygen in Catheterized Coronary Emergency Reperfusion

Region Skane·interventional·Posted Aug 26, 2011·Updated Aug 31, 2016

In Brief

A Phase 4 clinical trial evaluating Oxygen and Room air for ST Elevation Myocardial Infarction. Completed, enrolled 100 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSweden
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 26, 2011
Enrollment StartJan 1, 2012
Primary CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 14.8 years ago

Interventions

Oxygendrug

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

Room airdevice

Fitting of Oxymask TM