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

Shamir Medical Center (Assaf-Harofeh)

Status and phase: Unknown; Phase 3

Conditions: Myocardial Infarction Complicated With Cardiogenic Shock

Treatments: Procedure: Hypothermia

Study type: Interventional

Funder types: Other

Identifiers

NCT00846222

192/08

Details and patient eligibility

About

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

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 88 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

Mild theraputic hypothermia

Experimental group

Treatment:

Procedure: Hypothermia