This trial is active, not recruiting.

Condition myocardial infarction complicated with cardiogenic shock
Treatment hypothermia
Phase phase 3
Sponsor Assaf-Harofeh Medical Center
Start date February 2009
End date April 2010
Trial size 10 participants
Trial identifier NCT00846222, 192/08


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Mild therapeutic hypothermia, 33-34 celsius, for 12 hours

Primary Outcomes

Primary en point: presence of major adverse cardiac events (MACE) MACE definition: death and non-fatal re-infarction.
time frame: 30 days

Secondary Outcomes

Infarct size calculated by area under thr curve creatinine kinase according consecutive samples Reversal stunning by blinded observer echocardiographic assessment
time frame: 30 days

Eligibility Criteria

Male or female participants from 18 years up to 88 years old.

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 information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by Assaf-Harofeh Medical Center.