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Compares treatment options for Cardiogenic Shock
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
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join 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
You likely can't join 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
See the full eligibility criteria
- 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
- 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.
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Marseille, Bouche DU Rhone, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Marseille, Bouche DU Rhone, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.