Positive Association of US-FLI With the Severity of CAD

August 19, 2024 updated by: Tingqiu Wang, Chongqing Medical University

Positive Association Between Ultrasonographic Fatty Liver Indicator and the Severity of Coronary Artery Disease

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

190

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400000
        • Recruiting
        • The Second Affiliated Hospital of Chongqing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

All research subjects were from the Second Affiliated Hospital of Chongqing Medical University

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Non-CAD group
non-coronary artery disease group
CAD group
coronary artery disease group
Other: Observational study without human intervention
Observational study without human intervention
SS≤22 group
SYNTAX score ≤22
SS≥23 group
SYNTAX score ≥23
Other: Observational study without human intervention
Observational study without human intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SYNTAX score
Time Frame: 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.
at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chongqing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Estimated)

April 28, 2025

Study Completion (Estimated)

April 28, 2025

Study Registration Dates

First Submitted

August 2, 2024

First Submitted That Met QC Criteria

August 2, 2024

First Posted (Actual)

August 7, 2024

Study Record Updates

Last Update Posted (Actual)

August 21, 2024

Last Update Submitted That Met QC Criteria

August 19, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ChongqingM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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