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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 204
- 试验地点
- 2
- 主要终点
- The rate of ECMO placements
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
The rate of ECMO placements
时间窗: 1months
The rate of cardiac transplants
时间窗: 1months
Number of death from all causes
时间窗: 1MONTHS
The rate of implementation of the LVAD device
时间窗: 1 months
次要结局
- Number of death from all causes(1 year)
- The rate of ECMO placements(1 year)
- The rate of cardiac transplants(1 year)
- The rate of implementation of the LVAD device(1 year)