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The ULYSS study is a randomized, multicenter, interventional and prospective open-label clinical trial. It aims to evaluate the efficacy of the addition of an early IMPELLA CP support on top of optimal medical therapy and culprit lesion PCI compared to optimal medical care and culprit PCI in patients with an ACS complicated by a CS.
A transthoracic echography is required to exclude some non-inclusion criteria as soon as possible and before randomization.
Randomization will be performed after an informed consent is signed by the patient, a family member if he is unable to consent or thanks to the emergent consent procedure if all inclusion criteria are met and there are no non-inclusion criteria. A computer-generated randomization list will be drawn-up using a permuted block design (stratified on center). Each center will have a specific list.
Randomization 1:1 to one of the 2 groups
In all patients, emergent PCI of the culprit lesion will be performed.
Full description
Primary end-point
The primary endpoint (efficacy endpoint) is defined by a composite endpoint assessed at 1 month:
In case of refractory cardiogenic shock (RCS), the use ECMO should be discussed. IMPELLA CP implant is not allowed in the Control group but for venting when required after ECMO implant.
Secondary end-points - Efficacy
At hospital discharge and at one year, the same criteria will be assessed:
At hospital discharge , at one month and one year, the investigators also want to assess:
During hospital stay:
Additionally, the investigators will investigated safety and economic criteria of the two strategies.
At discharge, at one month and at one year, the investigators will assess:
The rational and methods of the health economic analysis are described in the overall document.
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Inclusion criteria
Exclusion criteria
Persons referred in articles L.1121-5 to L.1121-8 and L.1122-2 of the Public Health Code:
Onset of shock >24 hours
CS not related to ACS
Patient with prolonged cardiac arrest (>5 mins)
Contra-indications to Impella CP implantations:
Mechanical complication of myocardial infarction
Cerebral deficit with fixed dilated pupils or irreversible neurological pathology
Anoxic brain injury
Active bleeding
Contra-indication to antiplatelet or anticoagulant therapy
Life expectancy < 1 year
Primary purpose
Allocation
Interventional model
Masking
204 participants in 2 patient groups
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Central trial contact
Laurent BONELLO
Data sourced from clinicaltrials.gov
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