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RECRUITING

NCT05366452

Evaluation of the Efficacy of Early Implantation of a Percutaneous Left Ventricular Assist Devices in Acute Coronary Syndrome Complicated by Cardiogenic Shock Compared to Conventional Therapy: a Prospective, Multicenter, Randomized, Controlled and Open-label Clinical Trial

Sponsor: Assistance Publique Hopitaux De Marseille

View on ClinicalTrials.gov

Summary

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. * Control group: patients will receive IV inotropes associated or not with vasopressors according to the attached protocol and based on the current guidelines (annex 1) (2, 4) in addition to emergent culprit lesion PCI * Experimental group: patients will receive IMPELLA CP before PCI on top of conventional therapy based on the same protocol as the control group and emergent culprit PCI

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

204

Start Date

2022-12-19

Completion Date

2026-12

Last Updated

2023-01-25

Healthy Volunteers

Conditions

Cardiogenic Shock

Interventions

DEVICE

IMPELLA CP

Implantation of the IMPELLA CP will be performed using the femoral route in most patients. Echo guided puncture to gain access for IMPELLA CP will be encouraged and a local angiography will be promoted to check the feasibility of device implantation. The implantation will follow gold standard after obtaining an ACT \>250 s. As soon as the device is in place it will be started.

OTHER

Conventional therapy

The patients will receive up to date management according to the consensus of care regarding inotropes and vasopressors in CS (2,4). A dedicated protocol will ensure that management is similar between centers and in both groups. The shock team will be in charge of all therapeutic decisions.

Inclusion Criteria: * Age between 18 and 80 years old; * ACS ≤ 24 hours; * Cardiogenic shock defined by: * At least one criteria of low cardiac output defined by * SBP ≤ 90 mmHg or the need to use inotropes/vasopressors in order to obtain SBP\> 90 mmHg * CI ≤ 2.2L/min/m2 * At least one criteria of left overload defined by * clinical (killip class ≥ 2), * biological (NtproBNP \> 900pg/ml or BNP \> 400pg/ml), * radiological * non invasive or invasive hemodynamic evaluation * At least one criteria of malperfusion defined by * clinical (marbles, oliguria ≤ 0.5ml/min/kg, cold/clammy skin and extremities,..) * biological approach (arterial lactate ≥ 2mmol/L, ScVO2 \< 60%) * Stage C or D of the ACC classification of CS * Revascularization by PCI intended after coronary angiography; * Lack of significant femoral artery stenosis or other local contra-indication to a 14 Fr sheath; * Signed informed consent (patient and/or family/relative) or emergency procedure * Subject affiliated to or beneficiary of a social security system. Exclusion Criteria: * Persons referred in articles L.1121-5 to L.1121-8 and L.1122-2 of the Public Health Code: * Pregnant, parturient or breastfeeding woman * Person deprived of liberty for judicial or administrative decision * Adult person under legal protection (any form of public guardianship) * Onset of shock \>24 hours * CS not related to ACS * Patient with prolonged cardiac arrest (\>5 mins) * Contra-indications to Impella CP implantations: * Isolated right ventricular failure * LV thrombus * Mechanical aortic valve or heart constrictive device * Aortic valve stenosis or calcification (equivalent to an orifice area of 0.6cm2 or less) * Moderate to severe aortic insufficiency (echocardiographic assessment graded as ≥ 2) * Severe peripheral arterial disease precluding placement of the Impella system * Combined cardiorespiratory failure * Presence of an Atrial or Ventricular Septal Defect (including post infarctus VSD) * Left ventricular rupture Cardiac tamponade * 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

Locations (1)

Assistance Publique Hopitaux de Marseille

Marseille, Bouche DU Rhone, France