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

Study Overview
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Brief Summary
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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
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See above. 3 patients left to include.

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

Conditions
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Coronary Artery Disease, Myocardial Infarction

Intervention / Treatment
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* Procedure: Primary Percutaneous Coronary Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Remote Ischemic per-postconditioning<br>Remote conditioning is induced by inflation of a blood pressure cuff around the left thigh to 200 mmHg or 20 mmHg above systolic blood pressure (if >180 mmHg) for 5 min followed by deflation for 5 min. At least one of these conditioning cycles is performed before PCI is initiated. If time allows, cycles of remote conditioning (5 min leg ischemia and 5 min reperfusion) are repeated until PCI is performed. Following reperfusion, defined as first balloon inflation, four additional cycles of remote conditioning will be performed. | Procedure: Primary Percutaneous Coronary Intervention<br>* Primary Percutanous Coronary Intervention is performed in both Groups.<br>|
| Sham Comparator: Sham<br>The sham procedures include application of the cuff around the thigh but it is not inflated. Otheriwize normal primary PCI. | Procedure: Primary Percutaneous Coronary Intervention<br>* Primary Percutanous Coronary Intervention is performed in both Groups.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial infarct size expressed as a percentage to the myocardium at risk determined by Cardiac Magnetic Resonance |  | 6 months following index event |