Clinical Outcomes of Angioplasty Postconditioning

Overview

We previously demonstrated that postconditioning by coronary angioplasty can decrease infarct size (as measured by cardiac enzyme release) in patients with ongoing acute myocardial infarction. It is currently unknown whether postconditioning actually decreases or simply delays myocardial cell death during reperfusion. In addition, the long term effects of postconditioning on recovery of myocardial contraction remains elusive. The objective of the present study is to determine whether infarct size reduction by angioplasty postconditioning is maintained at 6 months and whether functional recovery is improved at one year post-infarction.

Full Title of Study: “Postconditioning and Functional Recovery After Acute Myocardial Infarction”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2008

Detailed Description

Randomized, controlled, single-blinded trial comparing postconditioning to control (no intervention). Postconditioning consists of four episodes of one minute inflation followed by one minute deflation of the angioplasty balloon, starting within one minute of reflow after direct stenting of the occluded coronary artery.

Interventions

  • Procedure: Postconditioning
    • Postconditioning during angioplasty
  • Procedure: standard angioplasty
    • standard angioplasty without postconditioning

Arms, Groups and Cohorts

  • Experimental: 1
    • Post-conditioning during angioplasty
  • Active Comparator: 2
    • standard angioplasty

Clinical Trial Outcome Measures

Primary Measures

  • Infarct size as measured by cardiac enzymes and MRI at day 5 to 7
    • Time Frame: during 72 hours after angioplasty, and at day 5 to 7

Secondary Measures

  • Myocardial contraction (LV ejection fraction, wall motion score index, strain rate) measured by echocardiography at 6 month.
    • Time Frame: at 6 month

Participating in This Clinical Trial

Inclusion Criteria

  • Male and female patients, aged more than 18, with suspected first acute myocardial infarction, within 6 hours of the onset of chest pain, with a need for emergency revascularization by angioplasty. Patients must display a fully occluded (TIMI zero flow) culprit coronary artery, absence of visible collaterals and exhibit TIMI flow >2 after direct stenting by angioplasty.

Exclusion Criteria

  • Cardiac arrest or cardiogenic shock
  • occlusion of the circumflex coronary artery

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospices Civils de Lyon
  • Provider of Information About this Clinical Study
    • Michel Ovize, Pr., Hospices Civils de Lyon
  • Overall Official(s)
    • michel Ovize, MD, Principal Investigator, Hospices Civils de Lyon

Citations Reporting on Results

Thibault H, Piot C, Staat P, Bontemps L, Sportouch C, Rioufol G, Cung TT, Bonnefoy E, Angoulvant D, Aupetit JF, Finet G, André-Fouët X, Macia JC, Raczka F, Rossi R, Itti R, Kirkorian G, Derumeaux G, Ovize M. Long-term benefit of postconditioning. Circulation. 2008 Feb 26;117(8):1037-44. doi: 10.1161/CIRCULATIONAHA.107.729780. Epub 2008 Feb 11.

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