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Clinical Trials/NCT00419198
NCT00419198
Completed
Not Applicable

Postconditioning and Functional Recovery After Acute Myocardial Infarction

Hospices Civils de Lyon1 site in 1 country91 target enrollmentSeptember 2005

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Myocardial Infarction
Sponsor
Hospices Civils de Lyon
Enrollment
91
Locations
1
Primary Endpoint
Infarct size as measured by cardiac enzymes and MRI at day 5 to 7
Status
Completed
Last Updated
6 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
September 2005
End Date
December 2008
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

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

Study Sites (1)

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