Reduction in Infarct Size by Remote Per-postconditioning in Patients With ST-elevation Myocardial Infarction

Reduction in Infarct Size by Remote Per-postconditioning in Patients With ST-elevation Myocardial Infarction in Stockholm (RECOND)

• Trial objective: To test the hypothesis that remote per-postconditioning in connection with primary PCI will reduce myocardial infarct size patients with STEMI.
• Trial Design: Placebo controlled randomized study with parallel groups
• Primary Endpoint: Myocardial infarct size expressed as a percentage of the myocardium at risk determined by Cardiac Magnetic Resonance (CMR) day 4-7
• Efficacy Parameters: Myocardial infarct size expressed as a percentage to the myocardium at risk determined by CMR at 6 months.
• Global left ventricular function determined by left ventricular ejection fraction determined by CMR.
• Microvascular obstruction determined by CMR day 4-7. Quantified ECV (extracellular volume) in left ventricular as myocardium at risk day 4-7 and remodelling parameters day 180.
• Safety Parameters: Major adverse cardiovascular events.

See above. 3 patients left to include.

Inclusion Criteria:

• Patient planned for primary PCI.
• Chest pain indicating myocardial ischemia with a duration >30 minutes and < 6 hours prior to randomization.
• ST elevations >0.1 mV (>0.2 mV in V2-V3) in > two contiguous leads in V1-V6.
• Informed consent.

Exclusion Criteria:

• Previous myocardial infarction based on medical history or Q-wave on ECG in other area
• Left Bundle Branch Block on ECG.
• Previous CABG
• Cardiac arrest
• Any contraindication for CMR.
• Clinical symptoms of claudication
• Treatment with glibenclamide or cyclosporine on admission.
• Any condition that may interfere with the possibility for the patient to comply with or complete the study protocol.