Coronary Artery Disease, Myocardial Infarction
Conditions
Brief summary
* 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.
Detailed description
See above. 3 patients left to include.
Interventions
PROCEDUREPrimary Percutaneous Coronary Intervention
Primary Percutanous Coronary Intervention is performed in both Groups.
Sponsors
John Pernow
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Myocardial infarct size expressed as a percentage of the myocardium at risk determined by Cardiac Magnetic Resonance | 4-7 days following index event |
Secondary
| Measure | Time frame |
|---|---|
| Myocardial infarct size expressed as a percentage to the myocardium at risk determined by Cardiac Magnetic Resonance | 6 months following index event |
Other
| Measure | Time frame |
|---|---|
| Global left ventricular function determined by left ventricular ejection fraction determined by CMR. | 4-7 days and 6 months following index event |
| Microvascular obstruction determined by CMR | 4-7 days following index event |
| Quantified ECV (extracellular volume) in left ventricular as myocardium at risk | 4-7 days following index event |
| Myocardial infarct size by CMR expressed as a percentage to the myocardium at risk determined by Bari or modified Approach Score with coronary angiography. | 5-7 days following index event |
Countries
Sweden
Outcome results
None listed