Cardiogenic ShockULYSSNCT05366452
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
A study testing IMPELLA CP and Conventional therapy in people with Cardiogenic Shock, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiogenic Shock
- What is being tested?
- IMPELLA CP and Conventional therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteFrance
- Study dates
- 19 Dec 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 19Show fewer
- 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.
Who cannot join
- 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
Show all 23Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hopitaux de Marseille
Marseille, Bouche DU Rhone, 13354
GIULIANI ALEXANDRA, alexandra.giuliani@ap-hm.fr
About this study
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.
Read more
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
Read the 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
- Being tested
- IMPELLA CP, Conventional therapy
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of death from all causes
Measured: 1MONTHS
The rate of ECMO placements
Measured: 1months
The rate of implementation of the LVAD device
Measured: 1 months
The rate of cardiac transplants
Measured: 1months
Secondary outcomes (4)
Number of death from all causes
Measured: 1 year
The rate of ECMO placements
Measured: 1 year
The rate of implementation of the LVAD device
Measured: 1 year
The rate of cardiac transplants
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start19 Dec 2022
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François CREMIEUX, Study director, Assistance Publique Hopitaux De MarseilleLAURENT BONELLO, Principal investigator, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05366452
- Sponsor's protocol ID
- 2020-A02337-32
- Acronym
- ULYSS
- Status last verified
- Jan 2023
- First submitted
- 4 May 2022
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37657594
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05366452
- Acronym / sponsor ID
- ULYSS / 2020-A02337-32
- Conditions
- Cardiogenic Shock
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 19 Dec 2022 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMPELLA CP GROUP | Experimental | Device: IMPELLA CPpatients will receive IMPELLA CP before PCI on top of conventional therapy based on the same protocol as the control group and emergent culprit PCI |
| CONTROL GROUP | Active comparator | Other: Conventional therapypatients 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (23 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMPELLA CPImplantation 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. | Device | IMPELLA CP GROUP |
| Conventional therapyThe 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. | Other | CONTROL GROUP |
Primary outcome
Number of death from all causes
Time frame: 1MONTHS
The rate of ECMO placements
Time frame: 1months
The rate of implementation of the LVAD device
Time frame: 1 months
The rate of cardiac transplants
Time frame: 1months
4 secondary outcomes
Number of death from all causes
Time frame: 1 year
The rate of ECMO placements
Time frame: 1 year
The rate of implementation of the LVAD device
Time frame: 1 year
The rate of cardiac transplants
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Derived from this study: PubMed 37657594Delmas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
François CREMIEUX study director
Assistance Publique Hopitaux De Marseille
LAURENT BONELLO principal investigator
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMPELLA CP and Conventional therapy in people with Cardiogenic Shock, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurent BONELLO (4 91 96 86 83 ext. +33, laurent.bonello@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of death from all causes (time frame: 1MONTHS). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05366452, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.