Clinical Outcomes of Angioplasty Postconditioning

Not Applicable

Completed

• Conditions: Acute Myocardial Infarction
• Interventions: Procedure: standard angioplasty; Procedure: Postconditioning

• Registration Number: NCT00419198
• Lead Sponsor: Hospices Civils de Lyon

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.

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2007-01-05
• Study First Submitted QC: 2007-01-05
• Study First Posted: 2007-01-08
• Primary Completion: 2008-03
• Study Completion: 2008-12
• Status Verified: 2010-03
• Last Update Submitted: 2019-05-23
• Last Update Posted: 2019-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	standard angioplasty	standard angioplasty
1	Postconditioning	Post-conditioning during angioplasty

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Michel Ovize; 🇫🇷 Lyon, France