[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646673":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":38,"locations":44,"responsibleParty":57,"collaborators":59,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":32,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":96,"whyStopped":32,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Leipzig Heart Science gGmbH","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Selective CRP Apheresis plus Standard of Care","EXPERIMENTAL","Participants receive standard of care for infarct-related cardiogenic shock plus selective C-reactive protein (CRP) apheresis using the PentraSorb®-CRP system. CRP apheresis is initiated within 5 ± 1 hours after randomization and repeated at 30 ± 4 hours and 54 ± 6 hours after randomization.",[13,14],"Device: Selective C-reactive protein apheresis (PentraSorb®-CRP)","Other: Standard of care",{"label":16,"type":17,"description":18,"interventionNames":19},"Standard of Care","ACTIVE_COMPARATOR","Participants receive guideline-directed standard of care for infarct-related cardiogenic shock without CRP apheresis.",[14],[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Selective C-reactive protein apheresis (PentraSorb®-CRP)","Selective removal of circulating C-reactive protein using the PentraSorb®-CRP adsorber system as an adjunct to guideline-directed standard of care.",[9],[27],"CRP Apheresis plus Standard of Care",{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Standard of care","Guideline-directed medical and interventional treatment for cardiogenic shock complicating acute myocardial infarction.",[9,16],null,[34],{"name":35,"affiliation":36,"role":37},"Prof. Dr. med. Holger Thiele Thiele","Heart Center Leipzig at University of Leipzig","PRINCIPAL_INVESTIGATOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":32,"email":43},"CRP-SHOCK Leipzig Heart Science gGmbH","CONTACT","+49 341 865 251556","CRP-SHOCK@leipzig-heart.de",[45],{"facility":36,"status":32,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":32},"Leipzig","Saxony","04289","Germany","DE",{"type":52,"coordinates":53},"Point",[54,55],12.37129,51.33962,{"lat":55,"lon":54},{"type":58,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[60,62],{"name":61,"class":6},"Helios Health Institute GmbH",{"name":36,"class":63},"UNKNOWN","100646673","crp-apheresis-in-infarct-related-cardiogenic-shock-100646673",false,"NCT07687017","CRP Apheresis in Infarct-Related Cardiogenic Shock","Selective C-Reactive Protein Apheresis in Cardiogenic Shock Complicating Acute Myocardial Infarction (CRP-SHOCK Trial)","CRP-SHOCK","Inclusion Criteria:\n\n* Cardiogenic shock complicating acute myocardial infarction with planned revascularization by percutaneous coronary intervention (PCI).\n* Cardiogenic shock defined as:\n* Systolic blood pressure \\\u003C90 mmHg for \\>30 minutes or requirement of catecholamine infusion to maintain systolic blood pressure ≥90 mmHg, and\n* Signs of impaired organ perfusion (at least one of the following): Cold, clammy skin and extremities, Altered mental status, Oliguria with urine output \\\u003C30 mL\u002Fhour, Arterial lactate \\>2 mmol\u002FL\n* C-reactive protein (CRP) level ≥7 mg\u002FL at baseline.\n* Age ≥18 years.\n* Informed consent provided by the participant or, if the participant is unable to consent, inclusion after assessment and documentation of the presumed patient's will by two physicians (one independent), with informed consent obtained as soon as possible.\n\nExclusion Criteria:\n\n* Fever (body temperature \\>38°C) or acute infection with fever within the last 14 days.\n* Chronic inflammatory disease.\n* Known history of severe hepatic failure.\n* Chronic kidney disease with creatinine clearance \\\u003C30 mL\u002Fmin\u002F1.73 m² prior to hospital admission.\n* Life expectancy \\\u003C12 months prior to cardiogenic shock.\n* Participation in another interventional clinical trial.\n* Pregnancy.\n* Resuscitation duration \\>30 minutes.\n* Cardiogenic shock due to causes other than acute myocardial infarction.\n* Onset of cardiogenic shock \\>12 hours before randomization.\n* Age \\>80 years.","ALL","18 Years","80 Years",{"count":76,"type":77},50,"ESTIMATED","INTERVENTIONAL",[80],"NA","Cardiogenic shock complicating acute myocardial infarction remains associated with high short-term mortality despite guideline-directed therapy. Systemic inflammation, particularly elevated C-reactive protein (CRP), may contribute to ongoing myocardial injury and organ dysfunction.\n\nThe CRP-SHOCK trial is an investigator-initiated, prospective, randomized, open-label, multicenter pilot study evaluating selective CRP apheresis as an adjunct to standard of care in patients with infarct-related cardiogenic shock. Patients are randomized to receive either standard therapy alone or standard therapy plus selective CRP apheresis using the PentraSorb®-CRP system.\n\nThe primary objective is to assess the effect of CRP apheresis on the CLIP score at 66 ± 8 hours after randomization. Secondary objectives include clinical outcomes, inflammatory biomarkers, and safety endpoints.",[83,84],"Cardiogenic Shock","Acute Myocardial Infarction (AMI)",[86,87,88,89,90,91,92,93,94,95],"C-reactive protein","CRP apheresis","Selective CRP apheresis","Inflammation","Infarct-related cardiogenic shock","Acute myocardial infarction","CLIP score","PentraSorb-CRP","Pilot study","Multicenter study","NOT_YET_RECRUITING","2026-07-03",{"date":99,"type":100},"2026-07-07","ACTUAL",{"date":102,"type":77},"2026-07-20",{"date":104,"type":77},"2027-10-31",{"name":5,"class":6},1]