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
Recruiting
N/A
Interventional Study
Cardiogenic Shock
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 204 (estimated)
- Sponsor
- Assistance Publique Hopitaux De Marseille · Other
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About This Trial
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-inclu…
Trial Locations
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Eligibility Criteria
Inclusion 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 …
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