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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Incidence of major adverse cardiovascular events (MACE)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group 1: MASLD participants with elevated liver fat burden
Participants with higher UDFF values.
Group 2: MASLD participants with lower liver fat burden
Participants with lower UDFF values.
结局指标
主要结局
Incidence of major adverse cardiovascular events (MACE)
时间窗: 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.
次要结局
- Subclinical cardiac dysfunction(Baseline, 6 months, 12 months, and 36 months)
研究者
Minjie Wan
Dr
First Affiliated Hospital, Sun Yat-Sen University