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Clinical Outcomes of Angioplasty Postconditioning

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00419198
First Posted: January 8, 2007
Last Update Posted: March 9, 2010
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.
Information provided by:
Hospices Civils de Lyon
  Purpose
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: None (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.
  Eligibility

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

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
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 ClinicalTrials.gov identifier (NCT number): NCT00419198


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

Responsible Party: Michel Ovize, Pr., Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00419198     History of Changes
Other Study ID Numbers: 2004.364
First Submitted: January 5, 2007
First Posted: January 8, 2007
Last Update Posted: March 9, 2010
Last Verified: March 2010

Keywords provided by Hospices Civils de Lyon:
Ischemia
Reperfusion
Myocardial infarction
Postconditioning

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