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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 204 (estimated)
• Sponsor: Assistance Publique Hopitaux De Marseille · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Detailed description

Primary end-point The primary endpoint (efficacy endpoint) is defined by a composite endpoint assessed at 1 month: * All cause death; * Need for ECMO; * LVAD device implantation; * Heart transplant 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: * All causes death; * Need for ECMO; * Need for LVAD device implantation or for heart transplant At hospital discharge , at one month and one year, the investigators also want to assess: * Myocardial infarctions * Stroke * Urgent revascularizations (any unplanned revascularization) * CV deaths * Procedural success (in-hospital) * Renal replacement therapies * Left ventricle ejection fraction at 1 and 12 month follow up * Quality of life at 1 and 12 months follow up (EQ5D questionnaire). During hospital stay: * Durations of catecholamines use * Length of initial-hospital stay * Length of stay in intensive care units (ICU + CCU) * The rate of renal replacement therapies * Lactates clearance during the first 24 hours * Area under the curve of CK release during the first 2 days * Left ventricle ejection fraction at 6 and 12 months follow-up * Quality of life at one month an one year (EQ5D questionnaire) Additionally, the investigators will investigated safety and economic criteria of the two strategies. \- Safety At discharge, at one month and at one year, the investigators will assess: * The rate of serious adverse events (urgent vascular surgery, transfusion, emboli). * The rate of BARC bleedings ≥3 * The rate of vascular complications requiring medical or surgical care * Hemostasis parameters, particularly hemolysis * Total number of RBC * Systemic emboli * Medico-economic the investigators will assess: * The cost of IMPELLA CP * The total costs of the intervention * The EQ5D at baseline and 12 months from PCI (Quality of life through utility health states assessment) * One year cost-utility analysis: calculated by an incremental cost-utility ratio in terms of costs per additional quality-adjusted life year (QALY). The rational and methods of the health economic analysis are described in the overall document.

Conditions

• Cardiogenic Shock

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-12-19
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2022-05-09
• Last updated: 2023-01-25

Locations

1 site across 1 country: France