This trial is active, not recruiting.

Conditions acute; myocardial infarction, complications, cardiogenic shock
Treatment mild hypothermia
Sponsor University of Leipzig
Start date August 2012
End date November 2015
Trial size 40 participants
Trial identifier NCT01890317, HZLCOOL1


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Induction of mild hypothermia for 24 hr with invasive cooling in addition to primary percutaneous coronary intervention and optimal medical therapy
mild hypothermia
Induction of mild hypothermia with invasive cooling for 24 hr in addition to primary percutaneous coronary intervention and optimal medical therapy.
(No Intervention)
Percutaneous coronary intervention and optimal medical therapy according to current guidelines

Primary Outcomes

Cardiac Power Index after 24 hr.
time frame: 24 hours

Secondary Outcomes

30-days mortality
time frame: 30 days
Change of hemodynamics over the first 48 hr.
time frame: During first 48 hr
Catecholamine dose and duration of catecholamine support
time frame: 30 days
Length of ICU-stay
time frame: 30 days
Length of mechanical ventilation
time frame: 30 days
time frame: 96 hours
Severe and moderate bleeding complications (GUSTO-definition)
time frame: 30 days
time frame: 30 days
time frame: 30 days
time frame: 30 days

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

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

Additional Information

Official title Randomized Pilot Study of Mild Hypothermia in Cardiogenic Shock Complicating Myocardial Infarction
Principal investigator Georg Fuernau, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by University of Leipzig.