Supplemental Oxygen in Catheterized Coronary Emergency Reperfusion

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01423929
• Date of registration: 25/08/2011
• Primary sponsor: Region Skane
• Public title: Supplemental Oxygen in Catheterized Coronary Emergency Reperfusion SOCCER
• Scientific title: Supplemental Oxygen in Catheterized Coronary Emergency Reperfusion
• Date of first enrolment: January 2012
• Target sample size: 100
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01423929
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Countries of recruitment

Sweden

Contacts

• Name: Mahin Akbarzadeh, MSc, RN

• Name: Ulf Ekelund, MD PhD
• Affiliation: Skåne University Hospital at Lund

Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

ST Elevation Myocardial Infarction

Intervention(s)

Device: Room air

Drug: Oxygen

Primary Outcome(s)

Myocardial salvage index [Time Frame: Day 4-6 after the acute PCI]

Secondary Outcome(s)

Area at risk [Time Frame: Day 4-6 after the acute PCI]

Blood oxygen saturation change [Time Frame: From inclusion to PCI start]

Change in wall motion score index [Time Frame: From index hospitalization to 6 months]

Doses of opioids (substance and mg) and betablockers (substance and mg) [Time Frame: Given before and during the PCI]

Ejection fraction [Time Frame: Day 4-6 after the acute PCI]

Infarct size [Time Frame: Day 4-6 after the acute PCI]

Infarct size [Time Frame: First 24 h after inclusion]

Microvascular obstruction [Time Frame: Day 4-6 after the acute PCI]

Pain difference [Time Frame: At randomization vs at PCI balloon inflation start]

Perceived health [Time Frame: At 6 months]

ST segment recovery [Time Frame: 90 minutes after acute PCI]

TIMI flow [Time Frame: During acute PCI]

Use of heart failure medications (beta blockers, ACEI, ARB, diuretics, digoxin and sinus node inhibitors etc) [Time Frame: At 6 months]

Wall motion score index on echocardiography [Time Frame: Day 2-3 after acute PCI]

Secondary ID(s)

2011-001452-11

Source(s) of Monetary Support

Please refer to primary and secondary sponsors