Clinical Outcomes of Angioplasty Postconditioning

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2008-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

Post-conditioning during angioplasty

Group Type EXPERIMENTAL

Postconditioning

Intervention Type PROCEDURE

Postconditioning during angioplasty

2

standard angioplasty

Group Type ACTIVE_COMPARATOR

standard angioplasty

Intervention Type PROCEDURE

standard angioplasty without postconditioning

Interventions

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Postconditioning

Postconditioning during angioplasty

Intervention Type PROCEDURE

standard angioplasty

standard angioplasty without postconditioning

Intervention Type PROCEDURE

Eligibility Criteria

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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.