Integrated Ultrasound-Derived Fat Fraction and 2D/4D HeartAI for Cardiovascular Risk Management in Patients With MASLD

Integration of Ultrasound-Derived Fat Fraction With 2D and 4D HeartAI for Cardiovascular Risk Management in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease: A Prospective Observational Cohort Study

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07545343

Acronym

MUCHAI

Enrollment

700

Registered

2026-04-22

Start date

2026-06-01

Completion date

2030-05-31

Last updated

2026-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular (CV) Risk, MASLD, Subclinical Cardiovascular Impairments

Keywords

Ultrasound-Derived Fat Fraction, Echocardiography, Cardiovascular Events, Major Adverse Cardiovascular Events

Brief summary

This prospective observational cohort study aims to evaluate the association between liver fat fraction measured by ultrasound-derived fat fraction (UDFF) and cardiac functional parameters assessed by 2D and 4D HeartAI in adult patients with metabolic dysfunction-associated steatotic liver disease (MASLD). Participants will undergo baseline assessment and repeat evaluations at 6, 12, and 36 months. The study will assess the diagnostic performance of integrated UDFF-HeartAI analysis for detecting subclinical cardiac abnormalities and identify predictors of cardiovascular risk progression and major adverse cardiovascular events in patients with MASLD.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Adults aged 18 to 75 years * Diagnosis of MASLD based on imaging or biopsy * Presence of at least one cardiometabolic risk factor, such as BMI ≥25 kg/m², type 2 diabetes mellitus, or dyslipidemia * No contraindication to ultrasound imaging

Exclusion criteria

* Significant alcohol consumption: \>20 g/day for women or \>30 g/day for men Secondary causes of hepatic steatosis, such as viral hepatitis or autoimmune liver disease * Known advanced heart failure (New York Heart Association class III-IV) * Recent cardiovascular event within 6 months * Pregnancy * Inability to complete follow-up

Design outcomes

Primary

Measure	Time frame	Description
Incidence of major adverse cardiovascular events (MACE)	Up to 36 months	Composite of cardiovascular death and non-fatal cardiovascular events, including non-fatal acute myocardial infarction, hospitalization for heart failure, unstable angina, hospitalization for atherosclerotic vascular disease, non-fatal stroke, transient ischemic attack, or lower limb ischemia.

Secondary

Measure	Time frame	Description
Subclinical cardiac dysfunction	Baseline, 6 months, 12 months, and 36 months	Defined by abnormalities such as left ventricular ejection fraction \<50% or abnormal left ventricular global longitudinal strain.

Countries

China

Outcome results