- 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.
Full Title of Study: “Reduction in Infarct Size by Remote Per-postconditioning in Patients With ST-elevation Myocardial Infarction in Stockholm (RECOND)”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: May 2015
See above. 3 patients left to include.
- Procedure: Primary Percutaneous Coronary Intervention
- Primary Percutanous Coronary Intervention is performed in both Groups.
Arms, Groups and Cohorts
- Active Comparator: Remote Ischemic per-postconditioning
- 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.
- Sham Comparator: Sham
- The sham procedures include application of the cuff around the thigh but it is not inflated. Otheriwize normal primary PCI.
Clinical Trial Outcome Measures
- Myocardial infarct size expressed as a percentage of the myocardium at risk determined by Cardiac Magnetic Resonance
- Time Frame: 4-7 days following index event
- Myocardial infarct size expressed as a percentage to the myocardium at risk determined by Cardiac Magnetic Resonance
- Time Frame: 6 months following index event
Participating in This Clinical Trial
- 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.
- 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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- John Pernow
- Provider of Information About this Clinical Study
- Sponsor-Investigator: John Pernow, Professor – Karolinska Institutet
- Overall Official(s)
- John Pernow, Professor, Principal Investigator, Karolinska Institutet
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