MASLD VCTE-C cohort: a prospective multicenter study linking liver fibrosis to cardiovascular outcomes in patients with metabolic dysfunction–associated steatotic liver disease

Background Metabolic dysfunction–associated steatotic liver disease (MASLD) is associated with increased risk of cardiovascular disease (CVD). The MASLD vibration-controlled transient elastography (VCTE)-C cohort is designed to examine the relationships among VCTE-derived hepatic measures, coronary artery calcification, and long-term cardiovascular outcomes in patients with MASLD. Methods This prospective, multicenter observational cohort will enroll 880 patients with VCTE-defined MASLD (controlled attenuation parameter [CAP] ≥248 dB/m) across 11 tertiary hospitals in the Republic of Korea. Additional eligibility criteria include at least one of the following: (i) type 2 diabetes; (ii) prediabetes; or (iii) obesity accompanied by at least one additional cardiovascular risk factor. Baseline assessments include noninvasive surrogates for liver fibrosis (fibrosis-4 index and liver stiffness measurement by VCTE) and steatosis (CAP by VCTE), coronary artery calcium scoring by noncontrast cardiac computed tomography, cardiometabolic profiling, and 10-year cardiovascular risk estimation primarily using the PREVENT equations, with the Pooled Cohort Equations and K-CVD model applied as complementary tools. Outcomes The primary outcome is time to the first occurrence of a four-component major adverse cardiovascular event, comprising acute myocardial infarction, stroke, cardiovascular death, or coronary revascularization. Secondary outcomes include other cardiovascular events, hepatic and renal outcomes, extrahepatic malignancy, and all-cause mortality. Participants will be followed for up to 10 years with serial VCTE; repeat coronary artery calcium scoring is planned at 5 and 10 years in eligible participants. Conclusion The MASLD VCTE-C cohort is expected to provide prospective evidence on liver–cardiovascular relationships that may inform integrated risk assessment in patients with MASLD. (KCT0012473).