Myocardial Infarction Complicated With Cardiogenic Shock Clinical Trial
| Verified date | February 2009 |
| Source | Assaf-Harofeh Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Ministry of Health |
| Study type | Interventional |
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
| Status | Active, not recruiting |
| Enrollment | 10 |
| Est. completion date | July 2010 |
| Est. primary completion date | April 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 88 Years |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Assaf Harofeh MC | Zerifin |
| Lead Sponsor | Collaborator |
|---|---|
| Assaf-Harofeh Medical Center |
Israel,
Dixon SR, Whitbourn RJ, Dae MW, Grube E, Sherman W, Schaer GL, Jenkins JS, Baim DS, Gibbons RJ, Kuntz RE, Popma JJ, Nguyen TT, O'Neill WW. Induction of mild systemic hypothermia with endovascular cooling during primary percutaneous coronary intervention for acute myocardial infarction. J Am Coll Cardiol. 2002 Dec 4;40(11):1928-34. — View Citation
Hale SL, Dave RH, Kloner RA. Regional hypothermia reduces myocardial necrosis even when instituted after the onset of ischemia. Basic Res Cardiol. 1997 Oct;92(5):351-7. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Primary en point: presence of major adverse cardiac events (MACE) MACE definition: death and non-fatal re-infarction. | 30 days | Yes | |
| Secondary | Infarct size calculated by area under thr curve creatinine kinase according consecutive samples Reversal stunning by blinded observer echocardiographic assessment | 30 days | No |