Ignite Creation Date:
2024-05-06 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05366452
Status:
RECRUITING
Last Update Posted:
2023-01-25
First Post:
2022-05-04
Brief 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
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Assistance Publique Hopitaux De Marseille
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ULYSS
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 11 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
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 11 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None