UnknownPhase 3

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

Israel10 participantsStarted 2009-02

Plain-language summary

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

Who can participate

Age range18 Years – 88 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Primary en point: presence of major adverse cardiac events (MACE) MACE definition: death and non-fatal re-infarction.

Timeframe: 30 days

Trial details

NCT IDNCT00846222

SponsorAssaf-Harofeh Medical Center

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2010-04

View on ClinicalTrials.gov More Myocardial Infarction Complicated With Cardiogenic Shock trials