NCT02021760
Completed
Not Applicable
Reduction in Infarct Size by Remote Per-postconditioning in Patients With ST-elevation Myocardial Infarction in Stockholm (RECOND)
John Pernow3 sites in 1 country120 target enrollmentMay 2013
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- John Pernow
- Enrollment
- 120
- Locations
- 3
- Primary Endpoint
- Myocardial infarct size expressed as a percentage of the myocardium at risk determined by Cardiac Magnetic Resonance
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
John Pernow
Professor
Karolinska Institutet
Eligibility Criteria
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-V
- •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.
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Myocardial infarct size expressed as a percentage to the myocardium at risk determined by Cardiac Magnetic Resonance(6 months following index event)
Study Sites (3)
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