[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626043":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":19,"locations":26,"responsibleParty":39,"collaborators":41,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":90,"sex":91,"minAge":92,"maxAge":10,"enrollmentInfo":93,"targetDuration":10,"studyType":96,"phases":10,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":104,"whyStopped":10,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Hospital Universitari Vall d'Hebron Research Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"ARTEMIs cohort",null,"* Clinical Use Case #1\\& 2: Adult patients diagnosed with MASLD\u002FMASH. Clinical Use Case #2, subgroup of patients with cardiovascular disease: Adult patients diagnosed with cardiac fibrosis, with or without MASLD.\n* Clinical Use Case #3: Adult patients diagnosed with cirrhosis.\n* Clinical Use Case #4: Adult patients diagnosed with HCC.\n* Control group: Adult patients with neither liver conditions nor cardiovascular events, as healthy control for the ARTEMIs models.",[13],"Other: Data recollection",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"Data recollection","Only data recollection for their use in the training, testing and early validation of computational models (but no other intervention) will be performed.",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":24,"email":25},"Jose Raul Herance, PhD","CONTACT","937372444","9344","raul.herance@vhir.org",[27],{"facility":28,"status":10,"city":29,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":10},"Vall d´Hebron Institute de Recerca (VHIR)","Barcelona","08035","Spain","ES",{"type":34,"coordinates":35},"Point",[36,37],2.15899,41.38879,{"lat":37,"lon":36},{"type":40,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[42,45,47,49,51,53,55,57,59,61,63,65,67,69,71,73,75,77,80],{"name":43,"class":44},"Matical Innovation SL","UNKNOWN",{"name":46,"class":6},"Assistance Publique - Hôpitaux de Paris",{"name":48,"class":6},"Jena University Hospital",{"name":50,"class":6},"Institut National de Recherche en Informatique et en Automatique",{"name":52,"class":6},"German Cancer Research Center",{"name":54,"class":6},"MEDEX",{"name":56,"class":44},"EUROPEAN LIVER PATIENTS ASSOCIATION",{"name":58,"class":6},"Betthera s.r.o.",{"name":60,"class":6},"Bournemouth University",{"name":62,"class":6},"University Hospital Heidelberg",{"name":64,"class":6},"Fundacion Para La Investigacion Hospital La Fe",{"name":66,"class":6},"University of Roma La Sapienza",{"name":68,"class":6},"Charite University, Berlin, Germany",{"name":70,"class":6},"Medical University of Vienna",{"name":72,"class":44},"Saint-Luc University Hospital",{"name":74,"class":6},"University of Freiburg",{"name":76,"class":6},"University of Leipzig",{"name":78,"class":79},"Sheba Medical Center","OTHER_GOV",{"name":81,"class":6},"Imperial College London","100626043","using-digital-twin-technology-and-clinical-decision-support-systems-to-improve-the-early-detection-personalised-treatment-and-long-term-monitoring-of-patients-across-the-full-spectrum-of-metabolic-associated-fatty-liver-disease-mafld-100626043",false,"NCT07430501","Using Digital Twin Technology and Clinical Decision Support Systems to Improve the Early Detection, Personalised Treatment, and Long-term Monitoring of Patients Across the Full Spectrum of Metabolic-associated Fatty Liver Disease (MAFLD).","AcceleRating the Translation of Virtual Twins Towards a pErsonalised Management of Steatotic Liver Patients","ARTEMIS","INCLUSION CRITERIA:\n\n1. \\- Clinical Use Case 1: Liver disease staging in MASLD patients - Prediction model of fibrosis changes (progression and regression), with ability to distinguish between fast and non-fast fibrosis progression among MASLD patients.\n\n   * Age ≥18 years\n   * Diagnosis of MASLD confirmed by radiological imaging (any type: MR, CT, PET, VCTE, US, USE...) or histology (gold standard, following MASH SAF score)\n   * With at least one follow-up of minimum 1 year after diagnosis of MASLD, with radiological imaging or histology\n2. \\- Clinical Use case 2: MASLD and progression of cardiovascular diseases\n\n   * Age ≥18 years MASLD patients regardless of disease stage of severity (from simple steatosis to cirrhosis)\n   * Patients without known heart disease\n   * Cardiovascular assessment available\n\n3.1- Clinical Use case 3-TIPS: Patients with cirrhosis and portal hypertension who receive TIPS placement.\n\n* Age ≥18 years\n* TIPS indication (Baveno VII), except pre-emptive and salvage TIPS.\n* Recurrent variceal bleeding after failure of the usual pharmacological and endoscopic methods\n* Refractory or recurrent ascites or difficult to treat\n* Refractory Hydrothorax\n* Patients with diagnosis of liver cirrhosis (based on laboratory parameters, clinical, endoscopic, radiological or histological findings), of any aetiology.\n\n3.2.- Clinical Use Case 3-LT: Patients with cirrhosis and portal hypertension who received liver transplantation.\n\n* Age ≥18 years\n* All patients with cirrhosis (all aetiologies) who were transplanted\n\n  4.- Clinical Use Case 4: Prediction of cardiac complications due to HCC treatments\\* (\\*Note: includes surgical interventions, ablation, TACE, TARE, SIRT and immunotherapies)\n* Age ≥18 years\n* Diagnosis of HCC (any aetiology)\n* Cross sectional imaging follow-up (any modality) of liver diseases 6 months after treatment\n* Non-cirrhotic or no more than Child-Pugh B cirrhosis.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Patients without history of prior HCC\n* Patients with a history of hypertension should be well controlled (\\\u003C 140\u002F90 mmHg) on a regimen of antihypertensive therapy.\n* With a minimum follow-up of two years or until death, after diagnosis of HCC\n\n  5.- Other populations (participation in control arms)\n* Age ≥18 years\n* Subjects presenting cardiac fibrosis, without a known MASLD diagnosis (as controls for use case 2)\n\nEXCLUSION CRITERIA:\n\n1. \\- Clinical Use Case 1: Liver disease staging in MASLD patients - Prediction model of fibrosis changes (progression and regression), with ability to distinguish between fast and non-fast fibrosis progression among MASLD patients.\n\n   * Missing data on blood glucose, BMI and metabolic status.\n   * Patients who have received systemic chemotherapy\n   * Patients with hepatitis B (HBV) and hepatitis C (HCV), alcoholic liver disease (more than 5 years of drinking history, equivalent to alcohol volume ≥ 30g \u002F D in male and ≥ 20g \u002F D in female), drug-induced liver disease or autoimmune hepatitis.\n   * Subjects having a significant risk of bleeding (platelet \\\u003C 50x109 \u002F L, prothrombin activity \\\u003C 50%)\n   * Presence of any other form of chronic liver, at the time of MASLD diagnosis.\n2. \\- Clinical Use case 2: MASLD and progression of cardiovascular diseases\n\n   * Association with another cause of liver disease\n   * History of hepatitis B or C\n   * Already known coronary artery disease\n   * History of cardiovascular events\n\n3.1- Clinical Use case 3-TIPS: Patients with cirrhosis and portal hypertension who receive TIPS placement.\n\n* Non-cirrhosis TIPS\n* Portosinusoidal vascular disease\n* Complete portal vein thrombosis\n* Patients with surgical porto-caval shunts.\n* Patients with evidence of current locally advanced or metastatic malignancy\n* Patients with acute or chronic heart failure (New York Heart Association \\[NYHA\\]).\n* Patients with chronic obstructive pulmonary disease GOLD grade III\u002FIV\n* Patients with chronic kidney disease requiring renal replacement therapy\n* Patients with a known infection with human immunodeficiency virus (HIV) or have clinical signs and symptoms consistent with current HIV infection\n* Patients with previous liver transplantation\n* Patients lost to follow-up and therefore have an incomplete 1-year follow-up\n\n3.2.- Clinical Use Case 3-LT: Patients with cirrhosis and portal hypertension who received liver transplantation.\n\n* Patients who were transplanted due to acute liver failure.\n* Patients who were already transplanted before (retransplant)\n* Patients who are lost to follow-up in the first 5 years after liver transplant.\n\n  4.- Clinical Use Case 4: Prediction of cardiac complications due to HCC treatments\\* (\\*Note: includes surgical interventions, ablation, TACE, TARE, SIRT and immunotherapies)\n* Mixed-tumor HCC based on radiological and\u002For pathological examination\n* Uncontrolled inter-current illness or psychiatric illness or social situations that would limit compliance with study requirements.\n* Subjects with history of another primary cancer\n* Fully recovered from any prior surgery and\u002For radiation and none within 2 weeks of initiating treatment.\n* Subjects with active hepatitis B or C on antiviral compounds may remain on such treatment, except for interferon.\n* Subjects with diagnosis of tumor of mixed origin, either from radiological or biopsy report.\n\n  5.- Other populations (participation in control arms)\n* Patients with diagnosis of MASLD",true,"ALL","18 Years",{"count":94,"type":95},7720,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to create a detailed virtual model to better understand how Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) develops. This model will also help predict heart problem at different stage of the disease.",[99],"Metabolic Dysfunction-Associated Steatotic Liver Disease",[101,102,103],"MASLD","Virtual twins","fatty liver patients","NOT_YET_RECRUITING","2026-02-17",{"date":107,"type":108},"2026-02-24","ACTUAL",{"date":110,"type":95},"2026-02-23",{"date":112,"type":95},"2027-09-02",{"name":5,"class":6},1]