Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
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

Led by Assistance Publique Hopitaux De Marseille · Updated on 2023-01-25

204

Participants Needed

1

Research Sites

206 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 80 years old
  • Acute coronary syndrome within 24 hours
  • Cardiogenic shock defined by low blood pressure (SBP ≤ 90 mmHg) or need for inotropes/vasopressors to maintain SBP > 90 mmHg, cardiac index ≤ 2.2 L/min/m2
  • At least one sign of left heart overload (clinical, biological, radiological, or hemodynamic)
  • At least one sign of poor blood flow (clinical or biological)
  • Stage C or D of the ACC classification of cardiogenic shock
  • Planned revascularization by PCI after coronary angiography
  • No significant femoral artery stenosis or local contraindications to a 14 Fr sheath
  • Signed informed consent (patient or family) or emergency consent procedure
  • Affiliated to or beneficiary of a social security system
Not Eligible

You will not qualify if you...

  • Pregnant, parturient, or breastfeeding women
  • Persons deprived of liberty by judicial or administrative decision
  • Adults under legal protection or guardianship
  • Onset of shock more than 24 hours prior
  • Cardiogenic shock not related to acute coronary syndrome
  • Prolonged cardiac arrest more than 5 minutes
  • Contraindications to Impella CP implantation including isolated right ventricular failure, left ventricular thrombus, mechanical aortic valve or heart constrictive device, severe aortic valve stenosis or calcification, moderate to severe aortic insufficiency, severe peripheral arterial disease, combined cardiorespiratory failure, atrial or ventricular septal defect, left ventricular rupture, cardiac tamponade
  • Mechanical complications of myocardial infarction
  • Cerebral deficit with fixed dilated pupils or irreversible neurological damage
  • Anoxic brain injury
  • Active bleeding
  • Contraindication to antiplatelet or anticoagulant therapy
  • Life expectancy less than 1 year

AI-Screening

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Trial Site Locations

Total: 1 location

1

Assistance Publique Hopitaux de Marseille

Marseille, Bouche DU Rhone, France, 13354

Actively Recruiting

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Research Team

L

Laurent BONELLO

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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