Mild Hypothermia in Cardiogenic Shock Complicating Myocardial Infarction (SHOCK-COOL)

University of Leipzig

Status: Completed

Conditions: Cardiogenic Shock; Acute; Myocardial Infarction, Complications

Treatments: Procedure: Mild hypothermia

Study type: Interventional

Funder types: Other

Identifiers

NCT01890317

HZLCOOL1

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Mild hypothermia

Experimental group

Description:

Induction of mild hypothermia for 24 hr with invasive cooling in addition to primary percutaneous coronary intervention and optimal medical therapy

Treatment:

Procedure: Mild hypothermia

Control

No Intervention group

Description:

Percutaneous coronary intervention and optimal medical therapy according to current guidelines