Clinical Outcomes of Angioplasty Postconditioning

This study has been completed.
Sponsor:
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00419198
First received: January 5, 2007
Last updated: March 8, 2010
Last verified: March 2010
  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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Michel Ovize, Pr., Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00419198     History of Changes
Other Study ID Numbers: 2004.364
Study First Received: January 5, 2007
Last Updated: March 8, 2010
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on April 15, 2014