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

Overview

- 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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2015

Detailed Description

See above. 3 patients left to include.

Interventions

  • 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

Primary 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

Secondary Measures

  • 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

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • 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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