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El ensayo clínico NCT07430501 (ARTEMIS) para Enfermedad Hepática Esteatósica Asociada a Disfunción Metabólica está aún no recluta. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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). (ARTEMIS) 7720 Observacional Virtual
- - Glossary CT : Computed Tomography CVD : Cardio-Vascular Disease HCC : Hepato Cellular Carcinoma MASH : Metabolic dysfunction-associated steatohepatitis MASLD : Metabolic dysfunction-Associated Steatotic Liver Disease MRI : Magnetic Resonance Imaging PET : Positron Emission Tomography SLD : Steatotic Liver Disease TACE : Trans-Arterial ChemoEmbolisation TARE : Trans-Arterial RadioEmbolisation TIPS : Transjugular...
AcceleRating the Translation of Virtual Twins Towards a pErsonalised Management of Steatotic Liver Patients
- ARTEMIS
- ARTEMIS_HE-HLTH2023
- 101136299 (Otra financiación) (Horizon Europe | RIA (Topic HORIZON-HLTH-2023-TOOL-05-03))
Virtual twins
fatty liver patients
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ARTEMIs cohort * Clinical Use Case #1\& 2: Adult patients diagnosed with MASLD/MASH. Clinical Use Case #2, subgroup of patients with cardiovascular disease: Adult patients diagnosed with cardiac fibrosis, with or without MASLD.
* Clinical Use Case #3: Adult patients diagnosed with cirrhosis.
* Clinical Use Case #4: Adult patients diagnosed with HCC.
* Control group: Adult patients with neither liver conditions nor cardiovascular ev...Mostrar más | 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. |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Liver disease progression and regression in MASLD patients | Probability rates of liver disease progression or regression in MASLD patients, including fibrosis stage changes and development of steatohepatitis (MASH), assessed using validated non-invasive tests, imaging techniques, and liver histology when available | From baseline assessment to last available follow-up (minimum 1 year, up to 5 years) |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Incidence of cardiovascular events in MASLD patients | Occurrence of cardiovascular events including myocardial infarction, stroke, atrial fibrillation, and heart failure in MASLD patients during retrospective follow-up. | Up to 5 years after baseline assessment |
- 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.
- Age ≥18 years
- Diagnosis of MASLD confirmed by radiological imaging (any type: MR, CT, PET, VCTE, US, USE...) or histology (gold standard, following MASH SAF score)
- With at least one follow-up of minimum 1 year after diagnosis of MASLD, with radiological imaging or histology
- Clinical Use case 2: MASLD and progression of cardiovascular diseases
- Age ≥18 years MASLD patients regardless of disease stage of severity (from simple steatosis to cirrhosis)
- Patients without known heart disease
- Cardiovascular assessment available
3.1- Clinical Use case 3-TIPS: Patients with cirrhosis and portal hypertension who receive TIPS placement.
- Age ≥18 years
- TIPS indication (Baveno VII), except pre-emptive and salvage TIPS.
- Recurrent variceal bleeding after failure of the usual pharmacological and endoscopic methods
- Refractory or recurrent ascites or difficult to treat
- Refractory Hydrothorax
- Patients with diagnosis of liver cirrhosis (based on laboratory parameters, clinical, endoscopic, radiological or histological findings), of any aetiology.
3.2.- Clinical Use Case 3-LT: Patients with cirrhosis and portal hypertension who received liver transplantation.
Age ≥18 years
All patients with cirrhosis (all aetiologies) who were transplanted
4.- Clinical Use Case 4: Prediction of cardiac complications due to HCC treatments* (*Note: includes surgical interventions, ablation, TACE, TARE, SIRT and immunotherapies)
Age ≥18 years
Diagnosis of HCC (any aetiology)
Cross sectional imaging follow-up (any modality) of liver diseases 6 months after treatment
Non-cirrhotic or no more than Child-Pugh B cirrhosis.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Patients without history of prior HCC
Patients with a history of hypertension should be well controlled (< 140/90 mmHg) on a regimen of antihypertensive therapy.
With a minimum follow-up of two years or until death, after diagnosis of HCC
5.- Other populations (participation in control arms)
Age ≥18 years
Subjects presenting cardiac fibrosis, without a known MASLD diagnosis (as controls for use case 2)
- 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.
- Missing data on blood glucose, BMI and metabolic status.
- Patients who have received systemic chemotherapy
- Patients with hepatitis B (HBV) and hepatitis C (HCV), alcoholic liver disease (more than 5 years of drinking history, equivalent to alcohol volume ≥ 30g / D in male and ≥ 20g / D in female), drug-induced liver disease or autoimmune hepatitis.
- Subjects having a significant risk of bleeding (platelet < 50x109 / L, prothrombin activity < 50%)
- Presence of any other form of chronic liver, at the time of MASLD diagnosis.
- Clinical Use case 2: MASLD and progression of cardiovascular diseases
- Association with another cause of liver disease
- History of hepatitis B or C
- Already known coronary artery disease
- History of cardiovascular events
3.1- Clinical Use case 3-TIPS: Patients with cirrhosis and portal hypertension who receive TIPS placement.
- Non-cirrhosis TIPS
- Portosinusoidal vascular disease
- Complete portal vein thrombosis
- Patients with surgical porto-caval shunts.
- Patients with evidence of current locally advanced or metastatic malignancy
- Patients with acute or chronic heart failure (New York Heart Association \[NYHA\]).
- Patients with chronic obstructive pulmonary disease GOLD grade III/IV
- Patients with chronic kidney disease requiring renal replacement therapy
- Patients with a known infection with human immunodeficiency virus (HIV) or have clinical signs and symptoms consistent with current HIV infection
- Patients with previous liver transplantation
- Patients lost to follow-up and therefore have an incomplete 1-year follow-up
3.2.- Clinical Use Case 3-LT: Patients with cirrhosis and portal hypertension who received liver transplantation.
Patients who were transplanted due to acute liver failure.
Patients who were already transplanted before (retransplant)
Patients who are lost to follow-up in the first 5 years after liver transplant.
4.- Clinical Use Case 4: Prediction of cardiac complications due to HCC treatments* (*Note: includes surgical interventions, ablation, TACE, TARE, SIRT and immunotherapies)
Mixed-tumor HCC based on radiological and/or pathological examination
Uncontrolled inter-current illness or psychiatric illness or social situations that would limit compliance with study requirements.
Subjects with history of another primary cancer
Fully recovered from any prior surgery and/or radiation and none within 2 weeks of initiating treatment.
Subjects with active hepatitis B or C on antiviral compounds may remain on such treatment, except for interferon.
Subjects with diagnosis of tumor of mixed origin, either from radiological or biopsy report.
5.- Other populations (participation in control arms)
Patients with diagnosis of MASLD
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