NCT05366452

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Dec 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Dec 2022Dec 2026

First Submitted

Initial submission to the registry

May 4, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 9, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

December 19, 2022

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

3.5 years

First QC Date

May 4, 2022

Last Update Submit

January 23, 2023

Conditions

Cardiogenic Shock

Outcome Measures

Primary Outcomes (4)

  • Number of death from all causes

    1MONTHS

  • The rate of ECMO placements

    1months

  • The rate of implementation of the LVAD device

    1 months

  • The rate of cardiac transplants

    1months

Secondary Outcomes (4)

  • Number of death from all causes

    1 year

  • The rate of ECMO placements

    1 year

  • The rate of implementation of the LVAD device

    1 year

  • The rate of cardiac transplants

    1 year

Study Arms (2)

IMPELLA CP GROUP

EXPERIMENTAL

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

Device: IMPELLA CP

CONTROL GROUP

ACTIVE COMPARATOR

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

Other: Conventional therapy

Interventions

IMPELLA CPDEVICE

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.

IMPELLA CP GROUP
Conventional therapyOTHER

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.

CONTROL GROUP

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +4 more criteria

You may not qualify if:

  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, Bouche DU Rhone, 13354, France

RECRUITING

Related Publications (1)

  • Delmas C, Laine M, Schurtz G, Roubille F, Coste P, Leurent G, Hraiech S, Pankert M, Gonzalo Q, Dabry T, Letocart V, Loubiere S, Resseguier N, Bonello L. Rationale and design of the ULYSS trial: A randomized multicenter evaluation of the efficacy of early Impella CP implantation in acute coronary syndrome complicated by cardiogenic shock. Am Heart J. 2023 Nov;265:203-212. doi: 10.1016/j.ahj.2023.08.066. Epub 2023 Aug 30.

    PMID: 37657594DERIVED

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShock

Study Officials

  • François CREMIEUX

    Assistance Publique Hopitaux De Marseille

    STUDY DIRECTOR

  • LAURENT BONELLO

    Assistance Publique Hopitaux De Marseille

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurent BONELLO

CONTACT

4 91 96 86 83laurent.bonello@ap-hm.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2022

First Posted

May 9, 2022

Study Start

December 19, 2022

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

January 25, 2023

Record last verified: 2023-01

Locations

FR(1)