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

Primary Purpose

Acute; Myocardial Infarction, Complications, Cardiogenic Shock

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Mild hypothermia
Sponsored by
University of Leipzig
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute; Myocardial Infarction, Complications focused on measuring Cardiogenic shock, acute myocardial infarction, mild hypothermia

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mild hypothermia

Control

Arm Description

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

Percutaneous coronary intervention and optimal medical therapy according to current guidelines

Outcomes

Primary Outcome Measures

Cardiac Power Index after 24 hr.
Cardiac Power Index after 24 hours as surrogate endpoint.

Secondary Outcome Measures

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

Full Information

First Posted
June 24, 2013
Last Updated
July 3, 2018
Sponsor
University of Leipzig
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1. Study Identification

Unique Protocol Identification Number
NCT01890317
Brief Title
Mild Hypothermia in Cardiogenic Shock Complicating Myocardial Infarction
Acronym
SHOCK-COOL
Official Title
Randomized Pilot Study of Mild Hypothermia in Cardiogenic Shock Complicating Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leipzig

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute; Myocardial Infarction, Complications, Cardiogenic Shock
Keywords
Cardiogenic shock, acute myocardial infarction, mild hypothermia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mild hypothermia
Arm Type
Experimental
Arm Description
Induction of mild hypothermia for 24 hr with invasive cooling in addition to primary percutaneous coronary intervention and optimal medical therapy
Arm Title
Control
Arm Type
No Intervention
Arm Description
Percutaneous coronary intervention and optimal medical therapy according to current guidelines
Intervention Type
Procedure
Intervention Name(s)
Mild hypothermia
Intervention Description
Induction of mild hypothermia with invasive cooling for 24 hr in addition to primary percutaneous coronary intervention and optimal medical therapy.
Primary Outcome Measure Information:
Title
Cardiac Power Index after 24 hr.
Description
Cardiac Power Index after 24 hours as surrogate endpoint.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
30-days mortality
Time Frame
30 days
Title
Change of hemodynamics over the first 48 hr.
Time Frame
During first 48 hr
Title
Catecholamine dose and duration of catecholamine support
Time Frame
30 days
Title
Length of ICU-stay
Time Frame
30 days
Title
Length of mechanical ventilation
Time Frame
30 days
Title
SAPS-II-Score
Description
Simplified Acute Physiology Score for the first 4 days
Time Frame
96 hours
Title
Severe and moderate bleeding complications (GUSTO-definition)
Time Frame
30 days
Title
Sepsis
Time Frame
30 days
Title
Pneumonia
Time Frame
30 days
Title
Stroke
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holger Thiele, MD
Organizational Affiliation
Heart Center Leipzig - University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Georg Fuernau, MD
Organizational Affiliation
Heart Center Leipzig - University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Internal Medicine/Cardiology, University of Leipzig - Heart Center
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04289
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
36005444
Citation
Cheng W, Fuernau G, Desch S, Freund A, Feistritzer HJ, Poss J, Buettner P, Thiele H. Circulating Monocyte Chemoattractant Protein-1 in Patients with Cardiogenic Shock Complicating Acute Myocardial Infarction Treated with Mild Hypothermia: A Biomarker Substudy of SHOCK-COOL Trial. J Cardiovasc Dev Dis. 2022 Aug 20;9(8):280. doi: 10.3390/jcdd9080280.
Results Reference
derived
PubMed Identifier
30026282
Citation
Fuernau G, Beck J, Desch S, Eitel I, Jung C, Erbs S, Mangner N, Lurz P, Fengler K, Jobs A, Vonthein R, de Waha-Thiele S, Sandri M, Schuler G, Thiele H. Mild Hypothermia in Cardiogenic Shock Complicating Myocardial Infarction. Circulation. 2019 Jan 22;139(4):448-457. doi: 10.1161/CIRCULATIONAHA.117.032722.
Results Reference
derived

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Mild Hypothermia in Cardiogenic Shock Complicating Myocardial Infarction

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