[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651657":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":50,"centralContacts":55,"locations":61,"responsibleParty":74,"collaborators":76,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":86,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":36,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":106,"overallStatus":118,"whyStopped":36,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Leipzig Heart Science gGmbH","OTHER",[8,15,20,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Microaxial flow pump + pulmonary artery catheter","EXPERIMENTAL","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.",[13,14],"Device: Microaxial flow pump (left ventricular assist device)","Device: Pulmonary artery catheter",{"label":16,"type":10,"description":17,"interventionNames":18},"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.",[13,19],"Procedure: Conventional hemodynamic monitoring",{"label":21,"type":22,"description":23,"interventionNames":24},"Medical therapy + pulmonary artery catheter","ACTIVE_COMPARATOR","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.",[14,25],"Procedure: Hemodynamic stabilization",{"label":27,"type":22,"description":28,"interventionNames":29},"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.",[19,25],[31,37,41,46],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DEVICE","Microaxial flow pump (left ventricular assist device)","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.",[16,9],null,{"type":32,"name":38,"description":39,"armGroupLabels":40,"otherNames":36},"Pulmonary artery catheter","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.",[21,9],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":36},"PROCEDURE","Conventional hemodynamic monitoring","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).",[27,16],{"type":42,"name":47,"description":48,"armGroupLabels":49,"otherNames":36},"Hemodynamic stabilization","Hemodynamic stabilization without hemodynamic protocol by pulmonary artery catheter. Hemodynamic stabilization through intravenous vasoactive agents, including vasopressors (e.g., norepinephrine) and\u002For 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.",[27,21],[51],{"name":52,"affiliation":53,"role":54},"Holger Thiele, Prof. Dr. med.","Heart Center Leipzig at University of Leipzig","PRINCIPAL_INVESTIGATOR",[56],{"name":57,"role":58,"phone":59,"phoneExt":36,"email":60},"DOUBLE SHOCK Leipzig Heart Science gGmbH","CONTACT","+49 341 865 251542","DOUBLE-SHOCK@leipzig-heart.de",[62],{"facility":53,"status":36,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":36},"Leipzig","Saxony","04289","Germany","DE",{"type":69,"coordinates":70},"Point",[71,72],12.37129,51.33962,{"lat":72,"lon":71},{"type":75,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR",[77,79,82],{"name":78,"class":6},"University of Southern Denmark",{"name":80,"class":81},"Boston Scientific Corporation","INDUSTRY",{"name":83,"class":6},"Heart Center Leipzig - University Hospital","100651657","routine-microaxial-heart-pump-support-and-protocolized-pulmonary-artery-catheter-monitoring-versus-standard-care-in-heart-attack-related-cardiogenic-shock-100651657",false,"NCT07762560","Routine Microaxial Heart Pump Support and Protocolized Pulmonary Artery Catheter Monitoring Versus Standard Care in Heart Attack-Related Cardiogenic Shock","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","DOUBLE-SHOCK","Inclusion Criteria:\n\nCardiogenic shock complicating AMI (STEMI or NSTEMI) plus obligatory all 4 of these:\n\n1. Planned immediate angiography and revascularization (preferred PCI)\n2. Systolic blood pressure \\\u003C100 mmHg or catecholamines required to maintain pressure \\>90 mmHg during systole\n3. Arterial lactate \\>2.0 mmol\u002FL\n4. Echocardiogram with LVEF \\\u003C40% or left ventricular outflow tract velocity time integral (LVOT-VTI) ≤12 cm\n\nExclusion Criteria:\n\n1. Age \\\u003C18 and \\>80 years\n2. Shock duration \\>12 hours\n3. Other causes of shock (hypovolemia, sepsis, pulmonary embolism or anaphylaxis).\n4. Shock due to mechanical complication of AMI\n5. 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 \\\u003C10 min are also eligible)\n6. After 390 included patients with OHCA, any OHCA will be an exclusion criterion\n7. Any unwitnessed OHCA\n8. Refractory cardiac arrest with ongoing chest compression\n9. Evidence of severe right ventricular failure\n10. Severe aorta valve regurgitation\u002Fstenosis\n11. Severe peripheral arterial obstructive disease precluding mAFP placement\n12. Abnormalities of the aorta precluding mAFP device placement\n13. Presence of a mechanical aortic valve prosthesis\n14. Left ventricular thrombus\n15. Infective endocarditis\n16. Life expectancy \\\u003C1 year due to comorbidities\n17. Mental disorder or language barrier that preclude informed consent\n18. Known pregnancy","ALL","18 Years","80 Years",{"count":96,"type":97},780,"ESTIMATED","INTERVENTIONAL",[100],"NA","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).\n\nThe main questions it aims to answer are:\n\n* 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?\n* Does protocol-based hemodynamic monitoring and optimization using a pulmonary artery catheter (PAC) improve survival compared to conventional intensive care monitoring?\n\nResearchers will compare four treatment combinations to see if mechanical circulatory support and\u002For advanced hemodynamic monitoring reduce mortality in AMI-CS patients:\n\n* Microaxial flow pump + pulmonary artery catheter\n* Microaxial flow pump + conventional monitoring\n* Medical therapy alone + pulmonary artery catheter\n* Medical therapy alone + conventional monitoring\n\nParticipants will:\n\n* Undergo immediate coronary angiography and PCI upon hospital admission Be randomly assigned to one of four treatment groups\n* Receive either immediate implantation of a microaxial flow pump or initial medical therapy with vasoactive agents following PCI\n* Be monitored either via pulmonary artery catheter with protocol-based hemodynamic optimization or via conventional intensive care monitoring\n* Be followed up at 30 days, 6 months and 12 monthsafter Randomization, with planned annual follow-up assessments for up to 10 years",[103,104,105],"Cardiogenic Shock","Acute Myocardial Infarction (AMI)","Heart Failure, Acute",[107,108,109,110,111,112,113,114,115,116,117],"2x2 factorial design","Mortality","Intensive care","Percutaneous coronary intervention","Hemodynamic monitoring","Mechanical circulatory support","Impella","Microaxial flow pump","AMI-CS","Acute myocardial infarction","Cardiogenic shock","NOT_YET_RECRUITING","2026-08-07",{"date":121,"type":122},"2026-08-13","ACTUAL",{"date":124,"type":97},"2026-10-01",{"date":126,"type":97},"2037-04",{"name":5,"class":6},1]