Post Cond No Reflow

Overview

After having shown that postconditioning allowed a significant 36% reduction of infarct size as assessed by blood levels of myocardial enzymes in acute myocardial patients, the investigators objective is to assess the effect of postconditioning in acute myocardial infarction (AMI) patients on microvascular obstruction lesions defined by cardiac MRI images.

Full Title of Study: “The POSTCONDITIONING and THE NO REFLOW Phenomenon in Acute Myocardial Infarction”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2009

Interventions

  • Procedure: postconditioning
    • Direct postconditioning (brief repeated cycle of 4 occlusion and desocclusion of the initially occluded culprit coronary artery) after primary direct stenting.

Arms, Groups and Cohorts

  • No Intervention: Control
    • 22 controls patients without post conditionment
  • Experimental: Intervention
    • 22 posconditioned patients

Clinical Trial Outcome Measures

Primary Measures

  • Extent of the area of microvascular obstruction
    • Time Frame: 5 days
    • Extent of the area of microvascular obstruction defined on post-gadolinium CMR images realized 48-72 hours after admission in each group

Secondary Measures

  • Size of the myocardial infarction
    • Time Frame: 5 days
    • Size of the myocardial infarction defined on post-gadolinium CMR images realized 48-72 hours after admission in each group.

Participating in This Clinical Trial

Inclusion Criteria

  • Patients > 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 IVA or RCA (not CA). – Artery guilty with TIMI flow = 0 Exclusion Criteria:

  • cardiac arrest before the angioplasty, – Cardiogenic shock – Occlusion of the artery circumflex responsible for the infarction – Magnetic resonance imaging: contre 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
  • Overall Official(s)
    • Pierre CROISILLE, MD, Study Director, Hospices Civils de Lyon

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