PCI Strategies in Patients with Acute Myocardial Infarction and Cardiogenic Shock.
Holger Thiele, Ibrahim Akin, Marcus Sandri...
https://pubmed.ncbi.nlm.nih.gov/29083953Actively Recruiting
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-01-14
400
Participants Needed
1
Research Sites
313 weeks
Total Duration
Researchers are evaluating whether early use of venoarterial extracorporeal membrane oxygenation (VA-ECMO) combined with an intra-aortic balloon pump (IABP) improves outcomes for patients who have acute myocardial infarction (heart attack) complicated by cardiogenic shock. Cardiogenic shock after a heart attack has a very high risk of death, around 40-50% within 30 days, and this trial aims to see if adding VA-ECMO and IABP to standard treatment can reduce this mortality rate. The study compares this combined treatment to optimal medical management alone, with an option to provide rescue VA-ECMO if needed for patients in the control group. Participants will be randomly assigned to one of two groups: the experimental group receives early VA-ECMO support plus IABP and standard medical care, while the control group receives standard medical care without IABP or other temporary circulatory support devices unless rescue VA-ECMO becomes necessary. VA-ECMO is initiated quickly, either onsite or by a mobile ECMO team if the patient is at a center without ECMO capability, with careful management and weaning protocols. IABP is inserted in the opposite femoral artery unless not possible. During the study, patients will be closely monitored for treatment failure at 30 days. Assessments include monitoring blood pressure, organ function, and signs of complications. Consent will be obtained from a close relative or surrogate before randomization, or from the patient when able. The study involves managing cardiogenic shock with standardized protocols and tracking outcomes to determine the potential benefit of early VA-ECMO plus IABP support over conventional treatment.
CONDITIONS
Assessment of ECMO in Acute Myocardial Infarction Cardiogenic Shock
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Total: 1 location
1
Hôpital Pitié Salpétrière
Paris, France, 75013
Actively Recruiting
A
Alain COMBES, MD, PhD
G
Gilles MONTALESCOT, MD, PhD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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