Adjunctive Mild Hypothermia Therapy to Primary Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction Complicated With Shock: A Feasibility Study

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-07-31

Brief Summary

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The purpose of this study is evaluate the safety and feasibility of mild therapeutic hypothermia (TH) during and 12 hours after primary percutaneous coronary intervention for acute myocardial infarction complicated with shock

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Detailed Description

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Conditions

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Myocardial Infarction Complicated With Cardiogenic Shock

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mild theraputic hypothermia

Group Type EXPERIMENTAL

Hypothermia

Intervention Type PROCEDURE

Mild therapeutic hypothermia, 33-34 celsius, for 12 hours

Interventions

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Hypothermia

Mild therapeutic hypothermia, 33-34 celsius, for 12 hours

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Recent myocardial infarction: 24 hours of start pain
* Pump failure cardiogenic shock (defined as persistent hypotension, systolic BP \< 90 mmHg, despite fluids and catecholamines infusion, with tissue hypoperfusion signs
* Candidate for immediate percutaneous reperfusion
* Maximal care support: mechanical ventilation, intraaortic balloon contrapulsation

Exclusion Criteria

* Cardiogenic shock related to mechanical complication: free wall rupture, acute mitral regurgitation, acute VSD, tamponade
* Pregnant women
* Absence of maximal support care

Minimum Eligible Age

18 Years

Maximum Eligible Age

88 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No