NCT06541132

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
190

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 7, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2025

Completed
Last Updated

August 21, 2024

Status Verified

August 1, 2024

Enrollment Period

2.8 years

First QC Date

August 2, 2024

Last Update Submit

August 19, 2024

Conditions

Keywords

Coronary Artery DiseaseMetabolic Dysfunction-associated Fatty Liver DiseaseSYNTAX scoreUltrasonography

Outcome Measures

Primary Outcomes (1)

  • SYNTAX score

    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

Study Arms (4)

Non-CAD group

non-coronary artery disease group

CAD group

coronary artery disease group

Other: Observational study without human intervention

SS≤22 group

SYNTAX score ≤22

SS≥23 group

SYNTAX score ≥23

Other: Observational study without human intervention

Interventions

Observational study without human intervention

CAD groupSS≥23 group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

RECRUITING

Related Publications (4)

  • Eslam M, Newsome PN, Sarin SK, Anstee QM, Targher G, Romero-Gomez M, Zelber-Sagi S, Wai-Sun Wong V, Dufour JF, Schattenberg JM, Kawaguchi T, Arrese M, Valenti L, Shiha G, Tiribelli C, Yki-Jarvinen H, Fan JG, Gronbaek H, Yilmaz Y, Cortez-Pinto H, Oliveira CP, Bedossa P, Adams LA, Zheng MH, Fouad Y, Chan WK, Mendez-Sanchez N, Ahn SH, Castera L, Bugianesi E, Ratziu V, George J. A new definition for metabolic dysfunction-associated fatty liver disease: An international expert consensus statement. J Hepatol. 2020 Jul;73(1):202-209. doi: 10.1016/j.jhep.2020.03.039. Epub 2020 Apr 8.

    PMID: 32278004BACKGROUND
  • Ballestri S, Nascimbeni F, Baldelli E, Marrazzo A, Romagnoli D, Targher G, Lonardo A. Ultrasonographic fatty liver indicator detects mild steatosis and correlates with metabolic/histological parameters in various liver diseases. Metabolism. 2017 Jul;72:57-65. doi: 10.1016/j.metabol.2017.04.003. Epub 2017 Apr 13.

    PMID: 28641784BACKGROUND
  • Buckley AJ, Thomas EL, Lessan N, Trovato FM, Trovato GM, Taylor-Robinson SD. Non-alcoholic fatty liver disease: Relationship with cardiovascular risk markers and clinical endpoints. Diabetes Res Clin Pract. 2018 Oct;144:144-152. doi: 10.1016/j.diabres.2018.08.011. Epub 2018 Aug 28.

    PMID: 30170074BACKGROUND
  • Liu Z, Que S, Xu J, Peng T. Alanine aminotransferase-old biomarker and new concept: a review. Int J Med Sci. 2014 Jun 26;11(9):925-35. doi: 10.7150/ijms.8951. eCollection 2014.

    PMID: 25013373BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Observation

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 2, 2024

First Posted

August 7, 2024

Study Start

July 1, 2022

Primary Completion

April 28, 2025

Study Completion

April 28, 2025

Last Updated

August 21, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations