Acute ST elevation myocardial infaction
Conditions
Interventions
Trade Name: Oxygen gas:
Medicinsk Oxygen AGA 100 %, Medicinsk gas, komprimerad
Product Name: Oxygen gas
Pharmaceutical Form: Inhalation gas
Sponsors
Skånes Universitetssjukhus Lund
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Infarct size on CMR - Area at risk on CMR - Ejection fraction on CMR - Microvascular obstruction on CMR - Pain difference (visual analog scale) at randomization vs at PCI balloon inflation start - Doses of opioids (substance and mg) and betablockers (substance and mg) given before and during the PCI - Infarct size as measured in-hospital with area under Troponin T curve (first 24 h). - ST-resolution after PCI - Coronary blood flow (TIMI flow) during PCI - Use of heart failure medications (beta blockers, ACEI, ARB, diuretics, digoxin and sinus node inhibitors etc) at 6 months - Perceived health (EQ-5D) at 6 months For the Echocardiography subgroup - 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 | — |
Countries
Sweden
Contacts
Public ContactUlf Ekelund
Skånes Universitetssjukhus Lund
Outcome results
None listed