Mild Hypothermia in Cardiogenic Shock Complicating Myocardial Infarction

Study Overview
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Brief Summary
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Prospective, randomized, single-center, controlled, open-label Pilot-study to investigate whether induction of mild hypothermia in addition to primary percutaneous coronary intervention and optimal medical therapy in myocardial infarction complicated by cardiogenic shock improves cardiac power index after 24 h.

Official Title
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Randomized Pilot Study of Mild Hypothermia in Cardiogenic Shock Complicating Myocardial Infarction

Conditions
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Acute; Myocardial Infarction, Complications, Cardiogenic Shock

Intervention / Treatment
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* Procedure: Mild hypothermia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute myocardial infarction complicated by cardiongenic shock Patients on mechanical ventilation at time of randomization Exclusion Criteria: Out of hospital resuscitation with indication for mild hypothermia mechanical complications after acute myocardial infarction duration of cardiogenic shock > 12 hours age > 90 years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mild hypothermia<br>Induction of mild hypothermia for 24 hr with invasive cooling in addition to primary percutaneous coronary intervention and optimal medical therapy | Procedure: Mild hypothermia<br>* Induction of mild hypothermia with invasive cooling for 24 hr in addition to primary percutaneous coronary intervention and optimal medical therapy.<br>|
| No Intervention: Control<br>Percutaneous coronary intervention and optimal medical therapy according to current guidelines | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Power Index after 24 hr. | Cardiac Power Index after 24 hours as surrogate endpoint. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-days mortality |  | 30 days | 
| Change of hemodynamics over the first 48 hr. |  | During first 48 hr | 
| Catecholamine dose and duration of catecholamine support |  | 30 days | 
| Length of ICU-stay |  | 30 days | 
| Length of mechanical ventilation |  | 30 days | 
| SAPS-II-Score | Simplified Acute Physiology Score for the first 4 days | 96 hours | 
| Severe and moderate bleeding complications (GUSTO-definition) |  | 30 days | 
| Sepsis |  | 30 days | 
| Pneumonia |  | 30 days | 
| Stroke |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiogenic shock, acute myocardial infarction, mild hypothermia