Overview

Supplemental Oxygen in Catheterized Coronary Emergency Reperfusion

Status:
Completed
Trial end date:
2016-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Region Skane
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