Routine Microaxial Heart Pump Support and Protocolized Pulmonary Artery Catheter Monitoring Versus Standard Care in Heart Attack-Related Cardiogenic Shock (DOUBLE-SHOCK)
2026年8月20日 更新者：Leipzig Heart Science gGmbH
Routine Microaxial Flow Pump Versus Radial Access Revascularization Without Routine Microaxial Flow Pump in Infarct-Related Cardiogenic Shock & Routine Pulmonary Artery Catheterization-based Monitoring With Protocolized Hemodynamic Optimization Versus Simplified Monitoring Without Protocolized Hemodynamic Optimization in Infarct-Related Cardiogenic Shock
The goal of this clinical trial is to learn which treatment strategies improve survival in adult patients with acute myocardial infarction complicated by cardiogenic shock (AMI-CS).
The main questions it aims to answer are:
- Does the immediate use of a left-sided microaxial flow pump (Impella) after percutaneous coronary intervention (PCI) improve survival compared to initial medical therapy alone?
- Does protocol-based hemodynamic monitoring and optimization using a pulmonary artery catheter (PAC) improve survival compared to conventional intensive care monitoring?
Researchers will compare four treatment combinations to see if mechanical circulatory support and/or advanced hemodynamic monitoring reduce mortality in AMI-CS patients:
- Microaxial flow pump + pulmonary artery catheter
- Microaxial flow pump + conventional monitoring
- Medical therapy alone + pulmonary artery catheter
- Medical therapy alone + conventional monitoring
Participants will:
- Undergo immediate coronary angiography and PCI upon hospital admission Be randomly assigned to one of four treatment groups
- Receive either immediate implantation of a microaxial flow pump or initial medical therapy with vasoactive agents following PCI
- Be monitored either via pulmonary artery catheter with protocol-based hemodynamic optimization or via conventional intensive care monitoring
- Be followed up at 30 days, 6 months and 12 monthsafter Randomization, with planned annual follow-up assessments for up to 10 years
研究概览
地位
尚未招聘
研究类型
介入性
注册 (估计的)
780
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：DOUBLE SHOCK Leipzig Heart Science gGmbH
- 电话号码：+49 341 865 251542
- 邮箱：DOUBLE-SHOCK@leipzig-heart.de
学习地点
-
-
Saxony
-
Leipzig、Saxony、德国、04289
- Heart Center Leipzig at University of Leipzig
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
Cardiogenic shock complicating AMI (STEMI or NSTEMI) plus obligatory all 4 of these:
- Planned immediate angiography and revascularization (preferred PCI)
- Systolic blood pressure <100 mmHg or catecholamines required to maintain pressure >90 mmHg during systole
- Arterial lactate >2.0 mmol/L
- Echocardiogram with LVEF <40% or left ventricular outflow tract velocity time integral (LVOT-VTI) ≤12 cm
Exclusion Criteria:
- Age <18 and >80 years
- Shock duration >12 hours
- Other causes of shock (hypovolemia, sepsis, pulmonary embolism or anaphylaxis).
- Shock due to mechanical complication of AMI
- Witnessed out-of-hospital cardiac arrest (OHCA) with chest compression >10 min in total (cardiac arrest occurring in ambulance or after hospital arrival is NOT an exclusion criterion and witnessed OHCA with duration of chest compression <10 min are also eligible)
- After 390 included patients with OHCA, any OHCA will be an exclusion criterion
- Any unwitnessed OHCA
- Refractory cardiac arrest with ongoing chest compression
- Evidence of severe right ventricular failure
- Severe aorta valve regurgitation/stenosis
- Severe peripheral arterial obstructive disease precluding mAFP placement
- Abnormalities of the aorta precluding mAFP device placement
- Presence of a mechanical aortic valve prosthesis
- Left ventricular thrombus
- Infective endocarditis
- Life expectancy <1 year due to comorbidities
- Mental disorder or language barrier that preclude informed consent
- Known pregnancy
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：阶乘赋值
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Microaxial flow pump + pulmonary artery catheter
Participants in this arm undergo immediate implantation of a left-sided microaxial flow pump (Impella) via the femoral artery following percutaneous coronary intervention (PCI).
The device is used to unload the left ventricle and augment cardiac output until hemodynamic stabilization is achieved.
In addition, participants receive a pulmonary artery catheter (PAC) inserted via a central venous access (jugular, subclavian, or femoral vein) for continuous hemodynamic monitoring and protocol-based optimization of cardiovascular function.
Target parameters include, e.g., cardiac output, pulmonary capillary wedge pressure (PCWP), systemic and pulmonary vascular resistance.
|
Percutaneous implantation of a left-sided microaxial flow pump via the femoral artery following PCI.
The device actively unloads the left ventricle by aspirating blood from the left ventricle and ejecting it into the ascending aorta, thereby augmenting cardiac output.
Implantation occurs immediately after PCI.
Insertion of a pulmonary artery catheter via central venous access (jugular, subclavian, or femoral vein) for continuous hemodynamic monitoring and protocol-based optimization of cardiovascular function.
Measured parameters include cardiac output, pulmonary capillary wedge pressure (PCWP), and systemic and pulmonary vascular resistance.
|
|
实验性的：Microaxial flow pump + conventional monitoring
Participants in this arm undergo immediate implantation of a left-sided microaxial flow pump (Impella) via the femoral artery following percutaneous coronary intervention (PCI).
The device is used to unload the left ventricle and augment cardiac output until hemodynamic stabilization is achieved.
Hemodynamic monitoring is performed using conventional intensive care methods, including arterial blood pressure measurement, central venous catheter, echocardiography, and serial laboratory parameters.
No pulmonary artery catheter is inserted.
|
Percutaneous implantation of a left-sided microaxial flow pump via the femoral artery following PCI.
The device actively unloads the left ventricle by aspirating blood from the left ventricle and ejecting it into the ascending aorta, thereby augmenting cardiac output.
Implantation occurs immediately after PCI.
Standard intensive care hemodynamic monitoring without pulmonary artery catheter, including invasive arterial blood pressure measurement, central venous pressure monitoring, echocardiography, and serial laboratory parameters (e.g., lactate, creatinine, liver enzymes, blood count).
|
|
有源比较器：Medical therapy + pulmonary artery catheter
Participants in this arm receive initial hemodynamic stabilization through guideline-recommended medical therapy following percutaneous coronary intervention (PCI), without immediate implantation of a mechanical circulatory support device.
In case of refractory cardiogenic shock unresponsive to medical therapy, escalation to mechanical circulatory support is permitted at the discretion of the treating physician.
In addition, participants receive a pulmonary artery catheter (PAC) inserted via a central venous access (jugular, subclavian, or femoral vein) for continuous hemodynamic monitoring and protocol-based optimization of cardiovascular function.
Target parameters include e.g., cardiac output, pulmonary capillary wedge pressure (PCWP), systemic and pulmonary vascular resistance.
|
Insertion of a pulmonary artery catheter via central venous access (jugular, subclavian, or femoral vein) for continuous hemodynamic monitoring and protocol-based optimization of cardiovascular function.
Measured parameters include cardiac output, pulmonary capillary wedge pressure (PCWP), and systemic and pulmonary vascular resistance.
Hemodynamic stabilization without hemodynamic protocol by pulmonary artery catheter.
Hemodynamic stabilization through intravenous vasoactive agents, including vasopressors (e.g., norepinephrine) and/or inotropes (e.g., dobutamine), administered according to current clinical guidelines.
Dosage and duration are determined by the treating physician based on hemodynamic response.
In case of refractory cardiogenic shock unresponsive to medical therapy, escalation to mechanical circulatory support is permitted at the discretion of the treating physician.
|
|
有源比较器：Medical therapy + conventional monitoring
Participants in this arm receive initial hemodynamic stabilization through guideline-directed medical therapy following percutaneous coronary intervention (PCI), without immediate implantation of a mechanical circulatory support device.
In case of refractory cardiogenic shock unresponsive to medical therapy, escalation to mechanical circulatory support is permitted at the discretion of the treating physician.
Hemodynamic monitoring is performed using conventional intensive care methods, including arterial blood pressure measurement, central venous catheter, echocardiography, and serial laboratory parameters.
No pulmonary artery catheter is inserted.
All participants receive standard intensive care treatment as clinically indicated.
|
Standard intensive care hemodynamic monitoring without pulmonary artery catheter, including invasive arterial blood pressure measurement, central venous pressure monitoring, echocardiography, and serial laboratory parameters (e.g., lactate, creatinine, liver enzymes, blood count).
Hemodynamic stabilization without hemodynamic protocol by pulmonary artery catheter.
Hemodynamic stabilization through intravenous vasoactive agents, including vasopressors (e.g., norepinephrine) and/or inotropes (e.g., dobutamine), administered according to current clinical guidelines.
Dosage and duration are determined by the treating physician based on hemodynamic response.
In case of refractory cardiogenic shock unresponsive to medical therapy, escalation to mechanical circulatory support is permitted at the discretion of the treating physician.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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all-cause death
大体时间：180 days after randomization
|
The primary outcome measure (endpoint) is the time to all-cause death during the first 180 days after randomization in all patients randomized.
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180 days after randomization
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Lactate clearance
大体时间：48 hours
|
Number of participants with reduction in arterial lactate measurement from baseline to 48 hours measurement.
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48 hours
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Time to normalization of lactate
大体时间：from date of randomization until the time in hours to stable normalization of arterial lactate <2 mmol/l.
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Time in hours to stable normalization of arterial lactate <2 mmol/l.
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from date of randomization until the time in hours to stable normalization of arterial lactate <2 mmol/l.
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Time to hemodynamic stabilization
大体时间：Time to hemodynamic stabilization from randomization up to 4 weeks.
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Time to hemodynamic stabilization from randomization up to 4 weeks.
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Need for escalation to (additional) MCS
大体时间：from date of randomization up to 4 weeks
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Number of patients requiring escalation to (additional) MCS from randomization up to 4 weeks.
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from date of randomization up to 4 weeks
|
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Vasoactive-inotropic score (VIS)
大体时间：from randomization to ICU discharge which usually occurs within 4 weeks
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The score has no metric; higher values indicate worse outcomes.
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from randomization to ICU discharge which usually occurs within 4 weeks
|
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Need for cardio-pulmonary resuscitation
大体时间：from date of randomization up to 4 weeks
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Number of patients requiring cardiopulmonary resuscitation.
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from date of randomization up to 4 weeks
|
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Length of intensive care unit stay
大体时间：from date of randomization to usually up to 4 weeks.
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Length of intensive care unit stay in days
|
from date of randomization to usually up to 4 weeks.
|
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Length of hospitalization
大体时间：from date of randomization to usually up to 6 months
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Length of hospital stay in days
|
from date of randomization to usually up to 6 months
|
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Quality of life (EuroQol 5D-5L)
大体时间：6month, 12 month after randomisation
|
Quality of life measured by the EuroQol 5D-5L questionnaire.
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions.
This decision results in a 1-digit number that expresses the level selected for that dimension.
The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
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6month, 12 month after randomisation
|
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Time to recurrent myocardial infarction
大体时间：From randomization to recurrent myocardial infarction or end of follow-up, assessed at 30 days, 6 months, and 12 months after randomization
|
From randomization to recurrent myocardial infarction or end of follow-up, assessed at 30 days, 6 months, and 12 months after randomization
|
|
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Time to rehospitalization for congestive heart failure
大体时间：during the first 30 days, 6 and 12 months after randomization
|
during the first 30 days, 6 and 12 months after randomization
|
|
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Time to death
大体时间：during the first 30 days and 12 months after randomization
|
during the first 30 days and 12 months after randomization
|
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Use of heart replacement therapy
大体时间：from date of randomization up to 6 months.
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Need for heart replacement therapy
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from date of randomization up to 6 months.
|
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Mortality and heart failure events
大体时间：at 6 and 12 months
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death, permanent LVAD/HTx and heart failure hospitalization
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at 6 and 12 months
|
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Implantable defibrillator
大体时间：from date of randomization up to 12 months.
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Need for implantable cardiac defibrillator
|
from date of randomization up to 12 months.
|
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Health-related costs
大体时间：from date of randomization to 6 months
|
Health related costs in € for each intervention.
|
from date of randomization to 6 months
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Mortality
大体时间：From randomization to death from any cause, assessed annually up to 10 years after randomization
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From randomization to death from any cause, assessed annually up to 10 years after randomization
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Sustained ventricular arrhythmia requiring cardioversion
大体时间：from date of randomization up to usually 4 weeks
|
Sustained ventricular arrhythmia requiring cardioversion
|
from date of randomization up to usually 4 weeks
|
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Bradycardia with pacing requirement
大体时间：from date of randomization up to usually 4 weeks.
|
Bradycardia requiring pacing.
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from date of randomization up to usually 4 weeks.
|
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Acute kidney injury according to KDIGO criteria
大体时间：from date of randomization up to usually 4 weeks.
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Acute kidney injury according to KDIGO criteria
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from date of randomization up to usually 4 weeks.
|
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Creatinine clearance (assessed by eGFR)
大体时间：From randomization to 72 hours after randomization
|
From randomization to 72 hours after randomization
|
|
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Requirement for renal replacement therapy
大体时间：from date of randomization up to usually 4 weeks.
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Acute kidney injury requiring renal replacement therapy.
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from date of randomization up to usually 4 weeks.
|
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Major bleeding according to BARC definition (BARC 3-5)
大体时间：from date of randomization up to usually 4 weeks
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Major bleeding according to BARC 3-5 criteria.
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from date of randomization up to usually 4 weeks
|
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Cumulative transfusion need
大体时间：from date of randomization up to 4 weeks.
|
Number of red packed blood cells for transfusion per patient .
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from date of randomization up to 4 weeks.
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Vascular access site related complications
大体时间：from date of randomization up to 4 weeks.
|
Number of vascular access site related complications.
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from date of randomization up to 4 weeks.
|
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Significant hemolysis
大体时间：from date of randomization up to usually 4 weeks.
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Significant hemolysis is defined as a plasma free hemoglobin >20 mg/dL (or an increase of 20 mg/dL above baseline values before initiation of support) and at least one of the following clinical findings occurring within 72 hours after initiation of support or within 24 (±2) hours of device removal:
|
from date of randomization up to usually 4 weeks.
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Sepsis with positive blood cultures
大体时间：from date of randomization up to usually 4 weeks.
|
Sepsis is defined as: Sepsis is caused by the immune system's response to a serious infection, most commonly bacteria, but also fungi, viruses, and parasites in the blood, urinary tract, lungs, skin, or other tissues. It will be defined as: Positive blood cultures and two or more of the following (SEPSIS-3 criteria):
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from date of randomization up to usually 4 weeks.
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Stroke
大体时间：from date of randomization up to usually 4 weeks.
|
Stroke will be classified in hemorrhagic (cranial CT, MRI, or autopsy) or non-hemorrhagic. Stroke is defined as an acute new neurological deficit ending in death or lasting longer than 24 hours, and classified by a physician as a stroke.
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from date of randomization up to usually 4 weeks.
|
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Thrombocytopenia
大体时间：from date of randomization up to 4 weeks.
|
Thrombocytopenia is defined as platelet count <50,000 platelets per microliter.
|
from date of randomization up to 4 weeks.
|
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Device malfunction
大体时间：from date of randomization up to 4 weeks.
|
from date of randomization up to 4 weeks.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Holger Thiele, Prof. Dr. med.、Heart Center Leipzig at University of Leipzig
- 首席研究员：Jacob Eifer Møller, Prof DMSc、Copenhagen University Hospital Righospitalet
- 首席研究员：Christian Hassager, Prof. DMSc、Rigshospitalet, Denmark
- 首席研究员：Anne Freund, PD Dr. med.、Heart Center Leipzig at Leipzig University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年10月1日
初级完成 (估计的)
2030年10月1日
研究完成 (估计的)
2037年4月1日
研究注册日期
首次提交
2026年7月3日
首先提交符合 QC 标准的
2026年8月7日
首次发布 (实际的)
2026年8月13日
研究记录更新
最后更新发布 (实际的)
2026年8月24日
上次提交的符合 QC 标准的更新
2026年8月20日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
其他研究编号
- DOUBLE-SHOCK Trial
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Individual participant data (IPD) will not be shared publicly.
Access to de-identified data may be considered upon reasonable request and subject to approval by the study sponsor and applicable ethics committees.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.