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

U

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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