NCT01890317

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 1, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

July 6, 2018

Status Verified

July 1, 2018

Enrollment Period

3.3 years

First QC Date

June 24, 2013

Last Update Submit

July 3, 2018

Conditions

Acute; Myocardial Infarction, ComplicationsCardiogenic Shock

Keywords

Cardiogenic shockacute myocardial infarctionmild hypothermia

Outcome Measures

Primary Outcomes (1)

  • Cardiac Power Index after 24 hr.

    Cardiac Power Index after 24 hours as surrogate endpoint.

    24 hours

Secondary Outcomes (10)

  • 30-days mortality

    30 days

  • Change of hemodynamics over the first 48 hr.

    During first 48 hr

  • Catecholamine dose and duration of catecholamine support

    30 days

  • Length of ICU-stay

    30 days

  • Length of mechanical ventilation

    30 days

  • +5 more secondary outcomes

Study Arms (2)

Mild hypothermia

EXPERIMENTAL

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

Procedure: Mild hypothermia

Control

NO INTERVENTION

Percutaneous coronary intervention and optimal medical therapy according to current guidelines

Interventions

Mild hypothermiaPROCEDURE

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

Mild hypothermia

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute myocardial infarction complicated by cardiongenic shock
  • Patients on mechanical ventilation at time of randomization

You may not qualify if:

  • Out of hospital resuscitation with indication for mild hypothermia
  • mechanical complications after acute myocardial infarction
  • duration of cardiogenic shock \> 12 hours
  • age \> 90 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Leipzig, Saxony, 04289, Germany

Location

Related Publications (2)

  • 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.

    PMID: 36005444DERIVED

  • 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.

    PMID: 30026282DERIVED

MeSH Terms

Conditions

Myocardial InfarctionShock, Cardiogenic

Interventions

Hypothermia, Induced

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShock

Intervention Hierarchy (Ancestors)

CryotherapyTherapeutics

Study Officials

  • Holger Thiele, MD

    Heart Center Leipzig - University Hospital

    STUDY CHAIR

  • Georg Fuernau, MD

    Heart Center Leipzig - University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-Director Clinic for Internal Medicine/Cardiology

Study Record Dates

First Submitted

June 24, 2013

First Posted

July 1, 2013

Study Start

August 1, 2012

Primary Completion

November 1, 2015

Study Completion

March 1, 2016

Last Updated

July 6, 2018

Record last verified: 2018-07

Locations

DE(1)