About this trial
In this initial investigator-initiated retrospective study, aim to analyze the enhanced liver fibrosis (ELF) scores in this high-risk population for NAFLD/nonalcoholic steatohepatitis(NASH)-related fibrosis. Study define 'high-risk' to include metabolic syndrome, which can be further defined by an atherosclerotic cardiovascular disease (ASCVD) score \>7.5, any diagnosis of hyperlipidemia, history of coronary artery disease, history of heart failure, hypertension and/or type 2 diabetes. Study would also like to compare the performance of this score with historical methods of fibrosis assessment, where applicable, including vibration-controlled transient elastography, magnetic resonance elastography, blood markers and liver biopsy. Study will assess the impact of ELF scores on predicting liver events in the time, have used it and determine if diet, lifestyle changes and/or pharmacotherapy will improve serial ELF scores. Will also seek to understand how ELF scores are distributed in our community.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: ≥ 18 years
NAFLD/NASH and non-NAFLD/NASH patients who have had an assessment with ELF score at Methodist Dallas Medical Center from November 2021 to December 2023.
Disqualifiers
Patients with incomplete data and those lost to follow up.
Trial population
Patients with 18 years of age, NAFLD/NASH and non-NAFLD/NASH who have assessed with ELF score at Methodist Dallas Medical Center from November 2021 to December 2023.
Trial design
Cohort
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Enhanced Liver Fibrosis (ELF )scores
Will measure the ELF scores-Reference range 7.14-9.55, the lowest value means better and highest value would mean worst
Instances of hospital admission for ascites, edema/anasarca, portal hypertensive-related bleeding or encephalopathy
Number of hospital admissions for ascites, edema/anasarca, portal hypertensive-related bleeding or encephalopathy
Demographics
age (years), gender (male/female), race (Caucasian, Black, Hispanic, Asian, Other)
Instances of comorbidities
Patients with hypertension(HTN), Hypersensitivity Lung Disease(HLD), Coronary Artery Disease(CAD),Heart Failure( HF), Atherosclerotic cardiovascular disease (ASCVD), Type 2 Diabetes Mellitus(T2DM) as comorbidities
Secondary outcomes
Abnormalities in Liver ultrasound (U/S) findings
rate of liver damage
Abnormalities in Liver biopsy results
Rate of cancerous cells in liver
Sponsors and contacts
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