[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100495221":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":31,"studyPopulation":32,"armGroups":33,"interventions":55,"overallOfficials":60,"centralContacts":65,"locations":73,"responsibleParty":90,"collaborators":92,"id":95,"slug":27,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":96,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":108,"studyType":109,"phases":27,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":76,"whyStopped":27,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Barts & The London NHS Trust","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":27},[9],{"measure":10,"description":11,"timeFrame":12},"The primary aim is to better understand the heterogeneity of the immune consequences and treatment responses in CS through identification of transcriptomic sub-phenotypes and their association with in-hospital mortality","This will be achieved through bloods sample collection, analysis and linked to the patient's clinical diagnosis and outcome.","through study completion, an average of 5 days",[14,17,19,21,23,25],{"measure":15,"description":16,"timeFrame":12},"Identify transcriptomic (and chemokine\u002Fcytokine) signatures at presentation that elucidate the pathobiology of CS and examine their subsequent evolution.","Bloods samples will be collected from patients during their hospital stay and corresponding analysis performed.",{"measure":18,"description":16,"timeFrame":12},"Correlate recently identified clinical phenotypes of CS with transcriptomic and inflammatory mediator signatures.",{"measure":20,"description":16,"timeFrame":12},"Identify transcriptomic and chemokine\u002Fcytokine signatures at presentation that improve prognostic accuracy in patients with CS",{"measure":22,"description":16,"timeFrame":12},"Investigate inter-individual heterogeneity in the dynamic transcriptomic response to CS through an eQTL mapping approach and identify context- specific regulatory genetic variants involving gene networks central to the pathogenesis of CS.",{"measure":24,"description":16,"timeFrame":12},"Identity novel therapeutic targets that might modulate the dysfunctional immune response to CS - \"drug discovery\"",{"measure":26,"description":16,"timeFrame":12},"Determine the extent to which the signatures and drivers of a dysfunctional immune response in CS are shared with other critical illness syndromes.",null,{"allocation":27,"interventionModel":27,"interventionModelDescription":27,"primaryPurpose":27,"observationalModel":29,"timePerspective":30,"maskingInfo":27},"COHORT","PROSPECTIVE","This is a prospective observational cohort study in 8-10 cardiac centres across Europe. We will recruit patients presenting with acute myocardial infarction (AMI) and CS who are supported medically (n=100); with extracorporeal membrane oxygenation (n=50); and with the Impella Device (n=50). We will also enrol patients who present with either AMI and no evidence of CS (n=50) or CS due to non-ischaemic pathologies (e.g. myocarditis: n=50) as comparators. The recruitment target is 300 patients.","All patients presenting to recruiting sites who fulfil study inclusion criteria and have no exclusion, will be considered. The majority of patients will be present through the heart attack centres and pathways. Some patients will, however, develop cardiogenic shock (CS) during their admission. These patients will be recruited from the coronary care units, intensive care units or cardiology wards and will be identified by clinicians who will alert research staff.",[34,39,43,47,51],{"label":35,"type":27,"description":36,"interventionNames":37},"Cardiogenic shock and MI","Patients presenting with acute myocardial infarction and cardiogenic shock who are supported medically (ie. inotropes +\u002F- intra aortic balloon pump only). N=50",[38],"Other: Observational study",{"label":40,"type":27,"description":41,"interventionNames":42},"Cardiogenic shock and MI wtih ECMO","Patients presenting with acute myocardial infarction and cardiogenic shock who are supported medically with ECMO (+\u002F- LV unloading device). N=50",[38],{"label":44,"type":27,"description":45,"interventionNames":46},"Cardiogenic shock and MI wtih Impella","Patients presenting with acute myocardial infarction and cardiogenic shock who are supported medically with Impella. N=50",[38],{"label":48,"type":27,"description":49,"interventionNames":50},"MI without cardiogenic shock","Patients presenting with acute myocardial infarction and cardiogenic shock as a control comparator",[38],{"label":52,"type":27,"description":53,"interventionNames":54},"Non ischemic Cardiogenic Shock ie myocarditis","Patients presenting with myocarditis and cardiogenic shock as a control comparator",[38],[56],{"type":6,"name":57,"description":58,"armGroupLabels":59,"otherNames":27},"Observational study","Blood sampling and clinical data collection",[35,40,44,48,52],[61],{"name":62,"affiliation":63,"role":64},"Alastair Proudfoot","Barts Heath NHS trust","PRINCIPAL_INVESTIGATOR",[66,70],{"name":62,"role":67,"phone":68,"phoneExt":27,"email":69},"CONTACT","02037658707","alastair.proudfoot1@nhs.net",{"name":71,"role":67,"phone":68,"phoneExt":27,"email":72},"Mervyn Andiapen","mervyn.andiapen@nhs.net",[74],{"facility":75,"status":76,"city":77,"state":27,"zip":27,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":85,"contacts":86},"Barts Health NHS trust","RECRUITING","London","United Kingdom","UK",{"type":81,"coordinates":82},"Point",[83,84],-0.12574,51.50853,{"lat":84,"lon":83},[87],{"name":88,"role":67,"phone":27,"phoneExt":27,"email":89},"Dan Jones","dan.jones8@nhs.net",{"type":91,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[93],{"name":94,"class":6},"University of Oxford","100495221",false,"NCT05728359","Genomic Determinants of Outcome in Cardiogenic Shock","Prospective Observational Study Investigating Genomic Determinants of Outcome From Cardiogenic Shock (GOlDilOCS)","Goldilocs","Inclusion Criteria:\n\n* All of the following are required for inclusion following screening:\n\n  * Willing to provide informed consent or appropriate consent from a nominated consultee or personal consultee\n  * Presentation within 24 hours of onset of ACS symptoms.\n  * CS can only be secondary to ACS (Type 1 MI STEMI or N-STEMI) or myocarditis\n  * Planned or completed revascularisation of culprit coronary artery\n\nCS will be defined by:\n\n* Systolic blood pressure \\\u003C90 mmHg for at least 30 minutes\n* A requirement for a continuous infusion of vasopressor or inotropic therapy to maintain systolic blood pressure \\> 90 mmHg.\n* Clinical signs of pulmonary congestion, plus signs of impaired organ perfusion with at least one of the following manifestations:\n\n  * altered mental status.\n  * cold and clammy skin and limbs.\n  * oliguria with a urine output of less than 30 ml per hour.\n  * elevated arterial lactate level of \\>2.0 mmol per litre.\n\nExclusion Criteria:\n\n* Any of the inclusion criteria not met and:\n\n  1. Unwilling to provide informed consent.\n  2. Echocardiographic evidence (recorded within 90 mins of end of PCI procedure) of mechanical cause for CS: eg ventricular septal defect, LV-free wall rupture, ischaemic mitral regurgitation.\n  3. Age \\\u003C18 and ≥80 years.\n  4. Shock from another cause (sepsis, haemorrhagic\u002Fhypovolaemic shock, anaphylaxis, etc).\n  5. Significant systemic illness\n  6. Known dementia of any severity\n  7. Comorbidity with life expectancy \\\u003C12 months.\n  8. Out-of-hospital cardiac arrest (OHCA) and any of the following:\n\n     1. No return of spontaneous circulation (ongoing resuscitation effort)\n     2. pH \\\u003C7\n     3. Without bystander CPR within 10 minutes of collapse\n  9. Arterial lactate level of \\\u003C2.0 mmol per litre.","ALL","18 Years","80 Years",{"count":106,"type":107},300,"ESTIMATED","1 Month","OBSERVATIONAL","The aim of this project is to understand the heterogeneity of both the immune consequences and treatment responses in CS. We will explore this heterogeneity through identification of transcriptomic sub-phenotypes and their association with outcomes, including therapeutic responses.",[112],"Cardiogenic Shock",[114,112,115,116,117,118],"ACS,","ECMO","Impella","Gene Expression","Endotype","2025-11-17",{"date":121,"type":122},"2025-11-18","ACTUAL",{"date":124,"type":122},"2022-08-08",{"date":126,"type":107},"2026-12-31",{"name":5,"class":6},1]