NCT06211244

Brief Summary

Background: Cardiovascular disease (CVD) is one of the leading causes of morbidity and mortality among dialysis patients. Eotaxin-1(also known as Eotaxin and CCL11), an eosinophil-specific chemoattractant that plays a role in a variety of pathologic conditions including allergy, coronary heart disease, and inflammatory bowel disease. CCL11 has been shown to be overexpressed in human atherosclerotic lesions. Moreover, eotaxin-1 levels are higher in non-uremic coronary artery disease patients than in healthy individuals. Methods: The study will enrolled 400 hemodialysis patients. Patients are diagnosed with coronary artery disease based on clinical presentation and confirmed by angiography. Serum eotaxin-1 and 8-isoprostane levels are determined by enzyme-linked immunosorbent assay (ELISA). High-sensitivity cTnI immunoassays and albumin redox state by high-performance liquid chromatography are used for measurements. Aim: In this study, we aimed to determine the eotaxin-1 concentrations of patients with coronary artery disease and to investigate the role of eotaxin-1 and markers of myocardial injury.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
291

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 18, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

May 2, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

June 6, 2025

Status Verified

June 1, 2025

Enrollment Period

8 months

First QC Date

January 8, 2024

Last Update Submit

June 4, 2025

Conditions

Keywords

coronary artery diseaseEotaxin-1hemodialysis patientsmyocardial injury

Outcome Measures

Primary Outcomes (1)

  • Analysis of biomarkers of serum eotaxin levels.

    Eotaxin levels and the serum levels of markers of myocardial injury as well as oxidative stress in a group of prevalent hemodialysis patients.

    1 years

Secondary Outcomes (5)

  • Redox state of serum albumin assays

    1 years

  • Analysis of biomarkers of MCP-1

    1 years

  • Analysis of biomarkers of IL-6

    1 years

  • Analysis of biomarkers of 8-isoprostane

    1 years

  • Analysis of biomarkers of High Sensitivity Troponin I

    1 years

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients have to be at least 20-years-old and on outpatient hemodialysis (HD) for at least 3 months.

You may qualify if:

  • Both sexes aged 20 years or over
  • Received stable hemodialysis at least 3 months.
  • Written informed consent.

You may not qualify if:

  • acute infection or malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tungs' Taichung MetroHarbour Hospital

Taichung, Taiwan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Wounds and InjuriesCoronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Paik Seong Lim, PhD

    Tungs' Taichung Metroharbour Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2024

First Posted

January 18, 2024

Study Start

May 2, 2024

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

June 6, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations