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
調査の概要
状態
まだ募集していません
研究の種類
介入
入学 (推定)
780
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：DOUBLE SHOCK Leipzig Heart Science gGmbH
- 電話番号：+49 341 865 251542
- メール：DOUBLE-SHOCK@leipzig-heart.de
研究場所
-
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Saxony
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Leipzig、Saxony、ドイツ、04289
- Heart Center Leipzig at University of Leipzig
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：階乗代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
実験的：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).
|
|
アクティブコンパレータ：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.
|
|
アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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all-cause death
時間枠：180 days after randomization
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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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Lactate clearance
時間枠：48 hours
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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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：from date of randomization to usually up to 4 weeks.
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Length of intensive care unit stay in days
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from date of randomization to usually up to 4 weeks.
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Length of hospitalization
時間枠：from date of randomization to usually up to 6 months
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Length of hospital stay in days
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from date of randomization to usually up to 6 months
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Quality of life (EuroQol 5D-5L)
時間枠：6month, 12 month after randomisation
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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
時間枠：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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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
時間枠：during the first 30 days, 6 and 12 months after randomization
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during the first 30 days, 6 and 12 months after randomization
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Time to death
時間枠：during the first 30 days and 12 months after randomization
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during the first 30 days and 12 months after randomization
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Use of heart replacement therapy
時間枠：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
時間枠：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
時間枠：from date of randomization up to 12 months.
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Need for implantable cardiac defibrillator
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from date of randomization up to 12 months.
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Health-related costs
時間枠：from date of randomization to 6 months
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Health related costs in € for each intervention.
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from date of randomization to 6 months
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Mortality
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Sustained ventricular arrhythmia requiring cardioversion
時間枠：from date of randomization up to usually 4 weeks
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Sustained ventricular arrhythmia requiring cardioversion
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from date of randomization up to usually 4 weeks
|
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Bradycardia with pacing requirement
時間枠：from date of randomization up to usually 4 weeks.
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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
時間枠：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)
時間枠：From randomization to 72 hours after randomization
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From randomization to 72 hours after randomization
|
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Requirement for renal replacement therapy
時間枠：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)
時間枠：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
時間枠：from date of randomization up to 4 weeks.
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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
時間枠：from date of randomization up to 4 weeks.
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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
時間枠：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:
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from date of randomization up to usually 4 weeks.
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Sepsis with positive blood cultures
時間枠：from date of randomization up to usually 4 weeks.
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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
時間枠：from date of randomization up to usually 4 weeks.
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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
時間枠：from date of randomization up to 4 weeks.
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Thrombocytopenia is defined as platelet count <50,000 platelets per microliter.
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from date of randomization up to 4 weeks.
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Device malfunction
時間枠：from date of randomization up to 4 weeks.
|
from date of randomization up to 4 weeks.
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
協力者
捜査官
- 主任研究者：Holger Thiele, Prof. Dr. med.、Heart Center Leipzig at University of Leipzig
- 主任研究者：Jacob Eifer Møller, Prof DMSc、Copenhagen University Hospital Righospitalet
- 主任研究者：Christian Hassager, Prof. DMSc、Rigshospitalet, Denmark
- 主任研究者：Anne Freund, PD Dr. med.、Heart Center Leipzig at Leipzig University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年10月1日
一次修了 (推定)
2030年10月1日
研究の完了 (推定)
2037年4月1日
試験登録日
最初に提出
2026年7月3日
QC基準を満たした最初の提出物
2026年8月7日
最初の投稿 (実際)
2026年8月13日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月24日
QC基準を満たした最後の更新が送信されました
2026年8月20日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- DOUBLE-SHOCK Trial
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
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.
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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