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Clinical Study of Extra-Corporal Life Support in Cardiogenic Shock Complicating Acute Myocardial Infarction (ECLS-SHOCK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02544594
Recruitment Status : Completed
First Posted : September 9, 2015
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
PD Dr. Stefan Brunner, Klinikum der Universitaet Muenchen

Brief Summary:
This study compares standard treatment plus Extra-Corporal Life Support (ECLS) versus standard treatment alone in patients with cardiogenic shock due to myocardial infarction.

Condition or disease Intervention/treatment Phase
Cardiogenic Shock Device: Extra-Corporal Life Support (ECLS) Phase 4

Detailed Description:

Cardiogenic shock is a serious complication of a myocardial infarction. Despite optimal treatment the mortality in patients with cardiogenic shock still exceeds 50% and surviving patients mostly suffer from severe heart failure due to an impaired cardiac function.

This study compares standard treatment plus Extra-Corporal Life Support (ECLS) versus standard treatment alone in patients with cardiogenic shock due to myocardial infarction.

The main study hypothesis is to explore if additional treatment with ECLS preserves cardiac function (left ventricular ejection fraction) in patients with cardiogenic shock complicating acute myocardial infarction.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Best medical therapy versus best medical therapy + ECLS in the treatment of cardiogenic shock complicating acute myocardial infarction
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Study of Extra-Corporal Life Support in Cardiogenic Shock Complicating Acute Myocardial Infarction
Study Start Date : November 2015
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack Shock

Arm Intervention/treatment
Active Comparator: Extra-Corporal Life Support (ECLS)
Standard treatment plus Extra-Corporal Life Support (ECLS) (from Sorin) in patients with cardiogenic shock due to myocardial infarction.
Device: Extra-Corporal Life Support (ECLS)
Extra-Corporal Life Support (ECLS) (from Sorin)

No Intervention: Standard treatment
Standard treatment alone without Extra-Corporal Life Support (ECLS) in patients with cardiogenic shock due to myocardial infarction.



Primary Outcome Measures :
  1. Left ventricular ejection fraction (LVEF) on day 30 [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. 30-day mortality [ Time Frame: 30 days ]
  2. Lactate levels [ Time Frame: up to 48 hours ]
  3. potentia hydrogenic levels [ Time Frame: 48 hours ]
  4. Length of mechanical ventilation [ Time Frame: 30 days ]
  5. Long-term mortality at 12 months [ Time Frame: up to 12 months ]
  6. Length of ICU stay [ Time Frame: 30 days ]
  7. Neurological Outcome (modified Rankin Scale) [ Time Frame: up to 12 months ]
  8. MACE (defined as cardiac death, non-fatal myocardial re-infarction, rehospitalisation for cardiac reasons and the need of CABG or PCI) [ Time Frame: up to 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Cardiogenic shock complicating acute myocardial (STEMI or NSTEMI) with

  • intended revascularization (PCI or CABG)
  • Systolic blood pressure < 90 mmHg > 30 min or inotropes required to maintain pressure > 90 mmHg during systole
  • Signs of left heart insufficiency and pulmonary congestion
  • Signs of impaired organ perfusion with at least one of the following:

    • Altered mental status
    • Cold, clammy skin
    • Urine output <30 ml/h
    • Serum lactate >2mmol/l
  • Informed consent

Exclusion Criteria:

  • Resuscitation > 60 minutes, ischemia > 10 minutes
  • No intrinsic heart action
  • Cerebral deficit with fixed dilated pupils
  • Mechanical infarction complication
  • Onset of shock > 12 h
  • Severe peripheral artery disease
  • Aortic regurgitation > II.°
  • Age > 80 years
  • shock of other cause
  • Other severe concomitant disease
  • participation in another trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02544594


Locations
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Germany
University Hospital Munich
Munich, Bavaria, Germany, 81377
Sponsors and Collaborators
Klinikum der Universitaet Muenchen
Investigators
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Principal Investigator: Stefan Brunner, MD Munich University Hospital
Study Chair: Steffen Massberg, MD Munich University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: PD Dr. Stefan Brunner, PD Dr. med., Klinikum der Universitaet Muenchen
ClinicalTrials.gov Identifier: NCT02544594    
Other Study ID Numbers: GE IDE MucM001-15
First Posted: September 9, 2015    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Myocardial Infarction
Shock, Cardiogenic
Infarction
Shock
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases