The effects of treatment with supplemental O2 during a large heart attack

Conditions: Acute ST elevation myocardial infaction
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2011-001452-11-SE

Lead Sponsor: Skånes Universitetssjukhus Lund

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- STEMI patient transported with ambulance to SUS Lund, SUS Malmö or Helsingborg hospital and accepted for acute PCI
- Symptom duration less than 6 hours
- Normal saturation (= 94 %) measured with pulse oximeter
- Informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

- Previous myocardial infarction
- Inability to make decision to participate; dementia and the like
- For cardiac magnetic resonance imaging (CMR): Significant claustrophobia, prostheses or other magnetic material inside the body

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To study whether 10 l/min O2 vs no supplemental O2 in the ambulance will result in different infarct size after acute balloon angioplasty (PCI) for ST elevation myocardial infarction;Secondary Objective: To study in the same patients whether 10 l/min O2 vs no supplemental O2 in the ambulance will result in different chest pain and perceived health at 6 months.;Primary end point(s): Myocardial salvage index on CMR;Timepoint(s) of evaluation of this end point: At day 4-6 after inclusion

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Infarct size on CMR<br>- Area at risk on CMR<br>- Ejection fraction on CMR<br>- Microvascular obstruction on CMR<br>- Pain difference (visual analog scale) at randomization vs at PCI balloon inflation start<br>- Doses of opioids (substance and mg) and betablockers (substance and mg) given before and during the PCI<br>- Infarct size as measured in-hospital with area under Troponin T curve (first 24 h).<br>- ST-resolution after PCI<br>- Coronary blood flow (TIMI flow) during PCI<br>- Use of heart failure medications (beta blockers, ACEI, ARB, diuretics, digoxin and sinus node inhibitors etc) at 6 months<br>- Perceived health (EQ-5D) at 6 months <br>For the Echocardiography subgroup<br>- Change in wall motion score index on echocardiography from index hospitalization to 6 months ;Timepoint(s) of evaluation of this end point: During ambulance transport, at day 4-6 after inclusion and at 6 months