Acute myocardial infarction
Conditions
Interventions
Trade Name: Oxygen gas:
Medicinsk Oxygen AGA 100 %, Medicinsk gas, komprimerad
Product Name: Oxygen gas
Pharmaceutical Form: Inhalation vapour
INN or Proposed INN: OXYGEN
Other descriptive name: Medic
Sponsors
Västra Götalands Center för utveckling av prehospital akutsjukvård
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients = 30 years of age with normal oxygen saturation (=90% on pulse oximeter) presenting to the ambulance service or the emergency department (ED) with classical symptoms suggestive of acute coronary syndrome (ACS) within the last 6 hours and significant ECG changes (characterized by ST-segment elevation = 0,2 mV V1-V4, or = 0.1 mV in other leads, ST-segment depression =0.1 mV in any lead, negative ischemic T-wave in leads V2-V6, pathological Q-wave in at least 2 adjacent leads, or left bundle branch block) or elevated cardiac biomarkers 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 2640 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3960
Exclusion criteria
Exclusion criteria: Hypoxia (oxygen saturation <90%), do not consent. Treatment with continuous oxygen therapy. Cardiac arrest prior to inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study whether 6 l/min O2 for 12 h vs no supplemental O2 will result in a reduction of one-year mortality in patients with acute myocardial infarction.;Secondary Objective: To study whether 6 l/min O2 for 12 h vs no supplemental O2 will result in a reduction of: -the incidence of heart failure, ventricular arythmias and reinfarction. -the infarct size as measured by cardiac magnetic resonance imaging ;Primary end point(s): One year all-cause mortality;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints are (1) mortality in all patients with diagnosed AMI, (2) major adverse cardiac events (MACE) within 30 days and 1 year, including all-cause mortality, re-infarction, hospitalization because of heart failure ;Timepoint(s) of evaluation of this end point: 30d and 1 y | — |
Countries
Sweden
Contacts
Public ContactJohan Herlitz
Västra Götalands Center för utveckling av prehospital akutsjukvård
Outcome results
None listed