[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655944":3},{"organization":4,"outcomesModule":7,"designInfo":51,"detailedDescription":57,"studyPopulation":11,"armGroups":58,"interventions":71,"overallOfficials":81,"centralContacts":85,"locations":91,"responsibleParty":101,"collaborators":11,"id":103,"slug":104,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":105,"sex":111,"minAge":112,"maxAge":11,"enrollmentInfo":113,"targetDuration":11,"studyType":116,"phases":117,"briefSummary":119,"conditions":120,"keywords":125,"overallStatus":134,"whyStopped":11,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"fullName":5,"class":6},"Chonnam National University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Composite of all-cause death or refractory shock within 48 hours after index percutaneous coronary intervention",null,"At 30 days after randomization",[14,16,19,23,25,28,30,32,34,36,39,41,43,45,47,49],{"measure":10,"description":11,"timeFrame":15},"At 12 months after randomization",{"measure":17,"description":11,"timeFrame":18},"All-cause death","At 30 days and 12 months after randomization",{"measure":20,"description":21,"timeFrame":22},"Number of participants with refractory shock within 48 hours after index percutaneous coronary intervention (PCI), assessed using prespecified clinical, hemodynamic, and arterial lactate criteria","Refractory shock is defined as any of: (1) rescue escalation to mechanical circulatory support beyond the randomized strategy, (2) acute cardiac arrest, or (3) persistent or worsening tissue hypoperfusion requiring at least one arterial lactate criterion AND at least one concurrent hemodynamic\u002Forgan-perfusion criterion.\n\nLactate criteria: two consecutive increases at approximately 2-hour intervals, 24-hour lactate clearance \\\u003C40 percent with lactate ≥4 mmol\u002FL at 24 hours, or persistent lactate ≥5 mmol\u002FL during hours 24-48.\n\nConcurrent criteria: increasing vasopressor requirement, use of ≥2 vasoactive agents; persistent mean arterial pressure \\\u003C65 mm Hg, urine output \\\u003C0.5 mL\u002Fkg\u002Fh for ≥6 hours; cardiac power output \\\u003C0.6 W, or cardiac index \\\u003C2.2 L\u002Fmin\u002Fm\\^2.\n\nProtocol-concordant post-PCI Impella CP insertion in the selective group is not, by itself, rescue escalation.","Within 48 hours after index percutaneous coronary intervention",{"measure":24,"description":11,"timeFrame":12},"Time from randomization to arterial lactate \u003C2.0 mmol\u002FL",{"measure":26,"description":11,"timeFrame":27},"24-hour arterial lactate clearance","At 24 hours after randomization",{"measure":29,"description":11,"timeFrame":18},"Cardiac death",{"measure":31,"description":11,"timeFrame":18},"Rate of ischemic or hemorrhagic stroke",{"measure":33,"description":11,"timeFrame":18},"Rate of renal replacement therapy",{"measure":35,"description":11,"timeFrame":18},"Rate of limb ischemia",{"measure":37,"description":11,"timeFrame":38},"Rate of clinically significant Impella CP-related hemolysis","At hospital discharge (up to 30 days)",{"measure":40,"description":11,"timeFrame":18},"Major bleeding (Bleeding Academic Research Consortium [BARC] type 3 or 5 bleeding)",{"measure":42,"description":11,"timeFrame":18},"Major vascular complications",{"measure":44,"description":11,"timeFrame":18},"Sepsis or bloodstream infection",{"measure":46,"description":11,"timeFrame":38},"Impella CP malfunction, malposition, or device-related cardiac or vascular injury",{"measure":48,"description":11,"timeFrame":15},"Rate of hospitalization for heart failure",{"measure":50,"description":11,"timeFrame":18},"Rate of stent thrombosis",{"allocation":52,"interventionModel":53,"interventionModelDescription":11,"primaryPurpose":54,"observationalModel":11,"timePerspective":11,"maskingInfo":55},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":56,"maskingDescription":11,"whoMasked":11},"NONE","* Study Objectives: To determine whether routine pre-percutaneous coronary intervention (PCI) Impella CP reduces the composite of all-cause death within 30 days after randomization or refractory shock within 48 hours after index PCI compared with revascularization first and selective post-PCI Impella CP in patients with acute myocardial infarction-related cardiogenic shock (AMICS) for whom Impella CP support is planned.\n* Study Background: AMICS is among the most lethal complications of acute myocardial infarction (AMI). It occurs in approximately 5-10% of patients with AMI, and short-term mortality remains approximately 40-50% despite rapid reperfusion and advances in critical care. Early culprit-vessel revascularization has been central to AMICS care, yet shock and multiorgan failure frequently persist after technically successful PCI.\n\nVasopressors and inotropes are often required to maintain blood pressure and organ perfusion, but high doses or prolonged use can increase myocardial oxygen demand, provoke arrhythmia, and worsen peripheral vasoconstriction. Routine mechanical circulatory support for unselected AMICS populations has not consistently improved outcomes.\n\nImpella CP is a percutaneous transvalvular microaxial flow pump inserted through the femoral artery. It transfers blood from the left ventricle to the ascending aorta, supporting systemic circulation while unloading the left ventricle and potentially reducing filling pressure, wall stress, and myocardial oxygen demand. The randomized DanGer-Shock (Danish Cardiogenic Shock) trial established a potential survival benefit in selected AMICS patients while reinforcing the need to optimize use and limit device-related harm.\n\nThe 2025 American guideline for the management of acute coronary syndromes states that, in selected patients with ST-segment elevation myocardial infarction (STEMI) and severe or refractory cardiogenic shock, the use of a microaxial flow pump may be reasonable to reduce the risk of death. However, in the DanGer-Shock trial, randomization concerned the use of the Impella CP, whereas the timing of device insertion, before or after PCI, was neither randomized nor specified by the study protocol. Accordingly, the guideline also acknowledges that the preferred timing of Impella insertion remains unclear. Therefore, the results of DanGer-Shock alone do not establish the superiority of pre-PCI over post-PCI insertion, and a randomized trial directly comparing these two strategies is warranted.\n\nThis study will randomly compare the clinical efficacy and safety of a routine pre-PCI Impella CP insertion strategy with a PCI-first strategy involving selective Impella CP insertion. It will determine whether the potential benefits of early left ventricular unloading and hemodynamic stabiliation outweigh the risks associated with pre-emptive device insertion in all patients, or whether restricting Impella CP use to patients with persistent shock after initial coronary revascularization can reduce unnecessary device use and related complications while providing comparable or superior clinical outcomes. This study has important clinical significance because it will address a key unresolved question following the DanGer-Shock trial, moving beyond \"whether to use the Impella CP\" to \"in whom and when it should be used\". By incorporating the potential benefit of avoiding device use in patients whose shock resolves with PCI alone, while simultaneously evaluating the risks of delaying circulatory support in those who require early mechanical support, this study is expected to provide a more individualized, evidence-based strategy for Impella CP use in patients with AMICS.\n\n\\- Study Hypothesis: Routine pre-PCI Impella CP will reduce the composite of all-cause death within 30 days after randomization or refractory shock within 48 hours after index PCI compared with revascularization first and selective post-PCI Impella CP.",[59,65],{"label":60,"type":61,"description":62,"interventionNames":63},"Routine pre-percutaneous coronary intervention (PCI) Impella CP","EXPERIMENTAL","In the pre-percutaneous coronary intervention (PCI) Impella CP group, Impella CP will be routinely inserted before culprit lesion PCI in patients with acute myocardial infarction-related cardiogenic shock.",[64],"Procedure: Routine pre-PCI Impella CP",{"label":66,"type":67,"description":68,"interventionNames":69},"Selective post-percutaneous coronary intervention (PCI) Impella CP","ACTIVE_COMPARATOR","The selective post-percutaneous coronary intervention (PCI) Impella CP group will undergo culprit-lesion PCI first; Impella CP will be inserted only if prespecified intra-procedural rescue criteria are met or shock persists or worsens after successful PCI for culprit lesion.",[70],"Procedure: Selective post-PCI Impella CP",[72,77],{"type":73,"name":74,"description":75,"armGroupLabels":76,"otherNames":11},"PROCEDURE","Routine pre-PCI Impella CP","In the PCI Impella CP group, Impella CP will be routinely inserted before culprit lesion PCI in patients with acute myocardial infarction-related cardiogenic shock.",[60],{"type":73,"name":78,"description":79,"armGroupLabels":80,"otherNames":11},"Selective post-PCI Impella CP","The selective post-PCI Impella CP group will undergo culprit-lesion PCI first; Impella CP will be inserted only if prespecified intra-procedural rescue criteria are met or shock persists or worsens after successful PCI for culprit lesion.\n\nIn the selective post-PCI group, immediate mechanical circulatory support will be instituted during PCI if any of the criteria are met. Impella CP is preferred when feasible. VA-ECMO may be initiated during resuscitation when Impella CP cannot be placed promptly or is insufficient.\n\nIn the selective post-PCI group, successful culprit-lesion revascularization is done without shock progession, PCI will be concluded without Impella CP only when all of the criteria are met.",[66],[82],{"name":83,"affiliation":5,"role":84},"Youngkeun Ahn","PRINCIPAL_INVESTIGATOR",[86],{"name":87,"role":88,"phone":89,"phoneExt":11,"email":90},"Min Chul Kim","CONTACT","82-10-4606-2643","kmc3242@hanmail.net",[92],{"facility":5,"status":11,"city":93,"state":11,"zip":11,"country":94,"countryCode":11,"cosmosGeoPoint":95,"geoPoint":100,"contacts":11},"Gwangju","South Korea",{"type":96,"coordinates":97},"Point",[98,99],126.91556,35.15472,{"lat":99,"lon":98},{"type":84,"investigatorFullName":87,"investigatorTitle":102,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Professor","100655944","optimal-timing-of-microaxial-flow-pumpimpella-cp-in-ami-related-cardiogenic-shock-100655944",false,"NCT07817472","Optimal Timing of Microaxial Flow Pump(Impella CP) in AMI-related Cardiogenic Shock","Routine PRe-PCI Versus Selective Post-PCI Impella CP Management and Evaluation in Acute Myocardial Infarction-Related Cardiogenic SHOCK","PRIME-SHOCK","Inclusion Criteria:\n\n* Age ≥19 years old\n* Acute myocardial infarction with culprit lesion requiring urgent percutaneous coronary intervention\n* Cardiogenic shock before culprit lesion percutaneous coronary intervention\n* Left ventricular ejection fraction ≤40%\n* Patients with persistent signs of shock despite medical therapy who are scheduled to undergo Impella CP insertion\n* Shock onset to randomization ≤12 hours\n\nExclusion Criteria:\n\n* Non-acute myocardial infarction-related shock\n* No clear culprit lesion\n* Mechanical complication of myocardial infarction\n* Predominant right ventricular or biventricular shock\n* Ongoing cardiopulmonary resuscitation at the time of screening\n* Refractory ventricular arrhythmia\n* Unwitnessed cardiac arrest without bystander cardiopulmonary resuscitation\n* Cardiopulmonary resuscitation duration \\>45 minutes\n* Glasgow Coma Scale \\\u003C8 after return of spontaneous circulation\n* Contraindication to Impella CP use\n* Prior mechanical circulatory support before randomization\n* Active major bleeding or inability to receive anticoagulation or antiplatelet therapy required for percutaneous coronary intervention and Impella CP support\n* Life expectancy \\\u003C1 year","ALL","19 Years",{"count":114,"type":115},126,"ESTIMATED","INTERVENTIONAL",[118],"NA","PRIME-SHOCK is a prospective, single-center, open-label, randomized, superiority trial. Eligible participants with AMICS and a clinical decision to use Impella CP will be randomized in a 1:1 ratio before culprit-lesion PCI. The routine pre-PCI group will undergo Impella CP insertion immediately after allocation and before culprit-lesion PCI. The selective post-PCI group will undergo culprit-lesion PCI first; Impella CP will be inserted only if prespecified intra-procedural rescue criteria are met or shock persists or worsens after successful PCI. If all post-PCI recovery criteria are met, PCI will be concluded without Impella CP.",[121,122,123,124],"Myocardial Infarction (MI)","Cardiogenic Shock","ST-Segment Elevation Myocardial Infarction(STEMI)","Non-ST-Segment Elevation Myocardial Infarction (NSTEMI)",[126,127,128,129,130,131,132,133],"Acute myocardial infarction","ST-segment elevation myocardial infarction","Non-ST-segment elevation myocardial infarction","Cardiogenic shock","Mechanical circulatory support","Microaxial flow pump","Impella CP","Percutaneous coronary intervention","NOT_YET_RECRUITING","2026-09-10",{"date":137,"type":138},"2026-09-14","ACTUAL",{"date":140,"type":115},"2026-10-01",{"date":142,"type":115},"2030-07-31",{"name":5,"class":6},1]