Clinical Outcomes of Angioplasty Postconditioning

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Completed

CT.gov ID

NCT00419198

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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 :

Sep 1, 2005

Actual Primary Completion Date :

Mar 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Infarct size as measured by cardiac enzymes and MRI at day 5 to 7 [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. [at 6 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.