Clinical Study of Extra-Corporal Life Support in Cardiogenic Shock Complicating Acute Myocardial Infarction
NCT ID: NCT02544594
Last Updated: 2019-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
42 participants
INTERVENTIONAL
2015-11-30
2019-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Extra-Corporal Life Support (ECLS)
Standard treatment plus Extra-Corporal Life Support (ECLS) (from Sorin) in patients with cardiogenic shock due to myocardial infarction.
Extra-Corporal Life Support (ECLS)
Extra-Corporal Life Support (ECLS) (from Sorin)
Standard treatment
Standard treatment alone without Extra-Corporal Life Support (ECLS) in patients with cardiogenic shock due to myocardial infarction.
No interventions assigned to this group
Interventions
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Extra-Corporal Life Support (ECLS)
Extra-Corporal Life Support (ECLS) (from Sorin)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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LMU Klinikum
OTHER
Responsible Party
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PD Dr. Stefan Brunner
PD Dr. med.
Principal Investigators
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Stefan Brunner, MD
Role: PRINCIPAL_INVESTIGATOR
Munich University Hospital
Steffen Massberg, MD
Role: STUDY_CHAIR
Munich University Hospital
Locations
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University Hospital Munich
Munich, Bavaria, Germany
Countries
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References
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Brunner S, Guenther SPW, Lackermair K, Peterss S, Orban M, Boulesteix AL, Michel S, Hausleiter J, Massberg S, Hagl C. Extracorporeal Life Support in Cardiogenic Shock Complicating Acute Myocardial Infarction. J Am Coll Cardiol. 2019 May 14;73(18):2355-2357. doi: 10.1016/j.jacc.2019.02.044. No abstract available.
Other Identifiers
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GE IDE MucM001-15
Identifier Type: -
Identifier Source: org_study_id
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