Positive Association of US-FLI With the Severity of CAD

Recruiting

• Conditions: Ultrasonography; Coronary Artery Disease of Significant Bypass Graft; SYNTAX Score; Metabolic Dysfunction-associated Fatty Liver Disease
• Interventions: Other: Observational study without human intervention

• Registration Number: NCT06541132
• Lead Sponsor: Chongqing Medical University

Brief Summary

As a multisystem disease, metabolic dysfunction-associated fatty liver disease (MAFLD) is closely linked to the onset and progression of coronary heart disease (CHD). Ultrasonographic fatty liver indicator (US-FLI) is a semi-quantitative tool for evaluating the degree of hepatic steatosis. Our study aims to explore the relationship between US-FLI based on MAFLD and the severity of CHD.

Detailed Description

204 patients who had invasive coronary angiography performed between July 2022 and December 2023 at the cardiology department of the Second Affiliated Hospital of Chongqing Medical University were included in this study. Collect clinical information and abdominal ultrasound images from each patient. Hepatic steatosis which quantified by US-FLI was evaluated by the echo contrast between liver and kidney, posterior attenuation of ultrasound beam, areas of focal sparing, display of hepatic vessels, gallbladder wall and diaphragm. Fatty liver was diagnosed when US-FLI≥2. The severity of CHD was evaluated using the SYNTAX score (SS), and a total of 100 CHD patients were ultimately diagnosed. CHD patients were further divided into the low-risk group (SS ≤ 22) (54 cases) and the medium-high-risk group (SS≥23) (46 cases). Multivariate logistic regression model was used to assess the relationship between US-FLI and SS in patients with MAFLD. The receiver operating characteristic curve was used to determine the accuracy, sensitivity and specificity of US-FLI in predicting SS.

Study Timeline

• Study Start: 2022-07-01
• Status Verified: 2024-08
• Study First Submitted: 2024-08-02
• Study First Submitted QC: 2024-08-02
• Study First Posted: 2024-08-07
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21
• Primary Completion: 2025-04-28
• Study Completion: 2025-04-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

• Patients older than 18 years old
• Patients underwent ICA due to chest pain, chest tightness or other reasons in our hospital from August 2022 to December 2023 were included in our study

Exclusion Criteria

• Incomplete clinical data
• previous coronary stent implantation
• no abdominal ultrasound examination
• poor ultrasound image quality
• congenital heart disease
• tumor
• thyroid diseases and infectious diseases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CAD group	Observational study without human intervention	coronary artery disease group
SS≥23 group	Observational study without human intervention	SYNTAX score ≥23

Primary Outcome Measures

Name	Time	Method
SYNTAX score	at baseline	The complexity of coronary artery disease (CAD) is a predictor of cardiovascular events in patients with \>50 % diameter stenosis as determined by SYNTAX score. The range of US-FLI is 0-8. Fatty liver was diagnosed when US-FLI ≥ 2.

Trial Locations

Locations (1)

The Second Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China