Delayed Postconditioning

Overview

The investigators previously reported that angioplasty postconditioning reduces infarct size (cardiac enzyme release) in STEMI patients with a fully occluded coronary artery at hospital admission. Animal studies have suggested that the time window for applying brief episodes of ischemia and reperfusion aimed at triggering postconditioning's protection is very narrow, i.e. does not expand beyond 1 minute after reflow. We sought to address whether this window might be larger in humans, i.e. whether STEMI patients might be protected several minutes after undergoing spontaneous reperfusion before admission coronary angiography.

Therefore, STEMI patients (onset of chest pain less than 12 hours) with a TIMI flow grade > 1 were eligible for that study. Angioplasty postconditioning was completed as already published and infarct size was assessed by measuring cardiac enzymes release.

Full Title of Study: “Delayed Angioplasty Postconditioning in STEMI Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2012

Interventions

  • Procedure: Postconditioning
    • Postconditioning consists of four cycles of one minute balloon inflation followed by one minute of balloon deflation, with the initial inflation being started within the first minute after reopening of the culprit coronary artery.
  • Procedure: Percutaneaous intervention
    • Conventional primary percutaneaous intervention

Arms, Groups and Cohorts

  • Experimental: Postconditionned
    • 36 postconditionned patients
  • Sham Comparator: Conventional intervention
    • 36 control patients with conventional primary percutaneaous intervention (PCI)

Clinical Trial Outcome Measures

Primary Measures

  • Size of the infarct
    • Time Frame: Day 5 post reperfusion
    • Size of the infarct estimated by magnetic resonance imaging at day 5 post-reperfusion

Secondary Measures

  • Contractile functional recovery
    • Time Frame: 6 months after reperfusion
    • Contractile functional recovery estimated by echocardiography at 6th month versus before discharge.

Participating in This Clinical Trial

Inclusion Criteria

  • Patient > 18 years old
  • Male or female
  • Presenting first myocardial infarction, with the beginning of pains < 12 hours,
  • Requiring a revascularisation by primary angioplasty or " rescue " (after failure of thrombolysis) on LAD or RCA (not Circumflex coronary artery).
  • TIMI flow grade at admission of 2 or 3
  • LV angiography (RAO30°) before angioplasty.

Exclusion Criteria

  • Cardiac arrest before the angioplasty
  • Cardiogenic shock
  • Occlusion of the artery circumflex responsible for the infarction
  • Visible collaterals to the area at risk
  • Magnetic resonance imaging: contra indication

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospices Civils de Lyon
  • Provider of Information About this Clinical Study
    • Sponsor

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