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

This study is ongoing, but not recruiting participants.

First Received: February 16, 2009 Last Updated: February 17, 2009 History of Changes

Sponsored by:	Assaf-Harofeh Medical Center
Information provided by:	Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:	NCT00846222

Purpose

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

Condition	Intervention	Phase
Myocardial Infarction Complicated With Cardiogenic Shock	Procedure: Hypothermia	Phase III

MedlinePlus related topics: Heart Attack Hypothermia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:

Primary en point: presence of major adverse cardiac events (MACE) MACE definition: death and non-fatal re-infarction. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Infarct size calculated by area under thr curve creatinine kinase according consecutive samples Reversal stunning by blinded observer echocardiographic assessment [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	February 2009
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Mild theraputic hypothermia: Experimental	Procedure: Hypothermia Mild therapeutic hypothermia, 33-34 celsius, for 12 hours

Eligibility

Ages Eligible for Study:	18 Years to 88 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00846222

Locations

Israel
Assaf Harofeh MC
Zerifin, Israel, 70300

Sponsors and Collaborators

Assaf-Harofeh Medical Center

More Information

Publications:

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.

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.

Responsible Party:	Assaf Harofeh MC ( Alex Blatt MD )
Study ID Numbers:	192/08
Study First Received:	February 16, 2009
Last Updated:	February 17, 2009
ClinicalTrials.gov Identifier:	NCT00846222 History of Changes
Health Authority:	Israel: Ministry of Health

Study placed in the following topic categories:

Hypothermia
Necrosis
Heart Diseases
Shock
Shock, Cardiogenic

Myocardial Ischemia
Vascular Diseases
Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Necrosis
Heart Diseases
Pathologic Processes
Shock, Cardiogenic
Shock
Myocardial Ischemia

Vascular Diseases
Cardiovascular Diseases
Ischemia
Infarction
Myocardial Infarction

ClinicalTrials.gov processed this record on May 07, 2009