Clinical Outcomes of Angioplasty Postconditioning

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00419198
Recruitment Status : Completed
First Posted : January 8, 2007
Last Update Posted : March 9, 2010
Information provided by:
Hospices Civils de Lyon

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Procedure: Postconditioning Procedure: standard angioplasty Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Postconditioning and Functional Recovery After Acute Myocardial Infarction
Study Start Date : September 2005
Actual Primary Completion Date : March 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Post-conditioning during angioplasty
Procedure: Postconditioning
Postconditioning during angioplasty

Active Comparator: 2
standard angioplasty
Procedure: standard angioplasty
standard angioplasty without postconditioning

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Myocardial contraction (LV ejection fraction, wall motion score index, strain rate) measured by echocardiography at 6 month. [ Time Frame: at 6 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00419198

Michel Ovize
Lyon, France, 69677
Sponsors and Collaborators
Hospices Civils de Lyon
Principal Investigator: michel Ovize, MD Hospices Civils de Lyon

Responsible Party: Michel Ovize, Pr., Hospices Civils de Lyon Identifier: NCT00419198     History of Changes
Other Study ID Numbers: 2004.364
First Posted: January 8, 2007    Key Record Dates
Last Update Posted: March 9, 2010
Last Verified: March 2010

Keywords provided by Hospices Civils de Lyon:
Myocardial infarction

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases