Adjunctive Mild Hypothermia Therapy to Primary Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction Complicated With Shock: A Feasibility Study
1 other identifier
interventional
10
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 16, 2009
CompletedFirst Posted
Study publicly available on registry
February 18, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedFebruary 18, 2009
February 1, 2009
1.2 years
February 16, 2009
February 17, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Primary en point: presence of major adverse cardiac events (MACE) MACE definition: death and non-fatal re-infarction.
30 days
Secondary Outcomes (1)
Infarct size calculated by area under thr curve creatinine kinase according consecutive samples Reversal stunning by blinded observer echocardiographic assessment
30 days
Study Arms (1)
Mild theraputic hypothermia
EXPERIMENTALInterventions
Mild therapeutic hypothermia, 33-34 celsius, for 12 hours
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Cardiogenic shock related to mechanical complication: free wall rupture, acute mitral regurgitation, acute VSD, tamponade
- Pregnant women
- Absence of maximal support care
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assaf Harofeh MC
Ẕerifin, 70300, Israel
Related Publications (2)
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.
PMID: 12475451BACKGROUNDHale 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.
PMID: 9486356BACKGROUND
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
February 16, 2009
First Posted
February 18, 2009
Study Start
February 1, 2009
Primary Completion
April 1, 2010
Study Completion
July 1, 2010
Last Updated
February 18, 2009
Record last verified: 2009-02