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

July 3, 2018 updated by: Holger Thiele, University of Leipzig

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Sachsen
      • Leipzig, Sachsen, Germany, 04289
        • Department of Internal Medicine/Cardiology, University of Leipzig - Heart Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mild hypothermia
Induction of mild hypothermia for 24 hr with invasive cooling in addition to primary percutaneous coronary intervention and optimal medical therapy
Procedure: 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: Control
Percutaneous coronary intervention and optimal medical therapy according to current guidelines

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leipzig

Investigators

  • Study Chair: Holger Thiele, MD, Heart Center Leipzig - University Hospital
  • Principal Investigator: Georg Fuernau, MD, Heart Center Leipzig - University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

June 24, 2013

First Submitted That Met QC Criteria

June 26, 2013

First Posted (Estimate)

July 1, 2013

Study Record Updates

Last Update Posted (Actual)

July 6, 2018

Last Update Submitted That Met QC Criteria

July 3, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HZLCOOL1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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