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Clinical Outcomes of Angioplasty Postconditioning

This study has been completed.
Information provided by:
Hospices Civils de Lyon Identifier:
First received: January 5, 2007
Last updated: March 8, 2010
Last verified: March 2010
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 Intervention
Acute Myocardial Infarction Procedure: Postconditioning Procedure: standard angioplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Postconditioning and Functional Recovery After Acute Myocardial Infarction

Resource links provided by NLM:

Further study details as provided by Hospices Civils de Lyon:

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

Enrollment: 91
Study Start Date: September 2005
Study Completion Date: December 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Post-conditioning during angioplasty
Procedure: Postconditioning
Postconditioning during angioplasty
Active Comparator: 2
standard angioplasty
Procedure: standard angioplasty
standard angioplasty without postconditioning

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.

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00419198

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

Responsible Party: Michel Ovize, Pr., Hospices Civils de Lyon Identifier: NCT00419198     History of Changes
Other Study ID Numbers: 2004.364
Study First Received: January 5, 2007
Last Updated: March 8, 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 processed this record on June 23, 2017