Back to resultsAdjunctive Mild Hypothermia Therapy to Primary Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction Complicated With Shock: A Feasibility Study
Primary Purpose
Myocardial Infarction Complicated With Cardiogenic Shock
Status
Unknown status
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Hypothermia
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction Complicated With Cardiogenic Shock
Eligibility 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
Sites / Locations
- Assaf Harofeh MC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mild theraputic hypothermia
Arm Description
Outcomes
Primary Outcome Measures
Primary en point: presence of major adverse cardiac events (MACE) MACE definition: death and non-fatal re-infarction.
Secondary Outcome Measures
Infarct size calculated by area under thr curve creatinine kinase according consecutive samples Reversal stunning by blinded observer echocardiographic assessment
Full Information
NCT ID
NCT00846222
First Posted
February 16, 2009
Last Updated
February 17, 2009
Sponsor
Assaf-Harofeh Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00846222
Brief Title
Adjunctive Mild Hypothermia Therapy to Primary Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction Complicated With Shock: A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
February 2009 (undefined)
Primary Completion Date
April 2010 (Anticipated)
Study Completion Date
July 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Assaf-Harofeh Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction Complicated With Cardiogenic Shock
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mild theraputic hypothermia
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Hypothermia
Intervention Description
Mild therapeutic hypothermia, 33-34 celsius, for 12 hours
Primary Outcome Measure Information:
Title
Primary en point: presence of major adverse cardiac events (MACE) MACE definition: death and non-fatal re-infarction.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Infarct size calculated by area under thr curve creatinine kinase according consecutive samples Reversal stunning by blinded observer echocardiographic assessment
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
88 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Assaf Harofeh MC
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
12475451
Citation
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. doi: 10.1016/s0735-1097(02)02567-6.
Results Reference
background
PubMed Identifier
9486356
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. doi: 10.1007/BF00788947.
Results Reference
background
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Adjunctive Mild Hypothermia Therapy to Primary Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction Complicated With Shock: A Feasibility Study
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