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OpenTrials
Completed

NCT Number: NCT01890317

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.

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Key information

Conditions

Acute; Myocardial Infarction, Complications Cardiogenic Shock Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Cardiogenic Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Leipzig, Saxony, 04289, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mild hypothermia

Procedure

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

Primary outcomes

  1. Cardiac Power Index after 24 hr.

    Time frame: 24 hours

    Cardiac Power Index after 24 hours as surrogate endpoint.

Secondary outcomes

  1. 30-days mortality

    Time frame: 30 days

  2. Change of hemodynamics over the first 48 hr.

    Time frame: During first 48 hr

  3. Catecholamine dose and duration of catecholamine support

    Time frame: 30 days

  4. Length of ICU-stay

    Time frame: 30 days

  5. Length of mechanical ventilation

    Time frame: 30 days

  6. SAPS-II-Score

    Time frame: 96 hours

    Simplified Acute Physiology Score for the first 4 days

  7. Severe and moderate bleeding complications (GUSTO-definition)

    Time frame: 30 days

  8. Sepsis

    Time frame: 30 days

  9. Pneumonia

    Time frame: 30 days

  10. Stroke

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Registry information

Official study title

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

Acronym: SHOCK-COOL

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Jul 1, 2013
Registry last updated
Jul 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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