The Predictive Value of Lubricin in Patients With Infective Endocarditis

February 11, 2024 updated by: Sevil Gulastı, Aydin Adnan Menderes University
The main goal of this study is to evaluate the predictability of the disease by measuring the serum lubricin levels in patients with infective endocarditis and in non-patients

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Infective endocarditis is a challenging disease with a wide range of clinical presentations, making it difficult to diagnose. Diagnosis primarily relies on clinical suspicion based on symptoms. Blood cultures or other microbial tests confirming the presence of infection and echocardiography are supportive diagnostic tools. Another marker that may become valuable in the near future for diagnosing infective endocarditis is Lubricin. Lubricin, a glycoprotein expressed by the PRG4 gene, has been found to have significantly elevated levels in the plasma of animals with damaged or infected heart valves compared to healthy animals. Furthermore, plasma lubricin levels can potentially serve as a biomarker in situations like endocardial injury and infection. Lubricin and Procalcitonin will be studied from the blood samples routinely collected. During this academic study, procalcitonin and lubricin values will be measured by investigators. Thus, the sensitivity and specificity of the Lubricin parameter in patients with infective endocarditis will be evaluated.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

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

Study Locations

  • Turkey
    • Zafer
      • Aydın, Zafer, Turkey, 09010
        • Sevil Gulasti

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

N/A

Sampling Method

Non-Probability Sample

Study Population

Along with 30 healthy individuals, 30 patients between the ages of 18 and 65 who meet the Duke criteria and do not receive antibiotic treatment due to infective endocarditis will be examined. Pregnant women will not be included in the study. During this examination, procalcitonin and lubricin values will be measured.

Description

Inclusion Criteria:

  • The patient must be between 18 and 65 years old
  • Patients diagnosed with infective endocarditis according to the Duke criteria

Exclusion Criteria:

- The patient being pregnant

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
Patients with infective endocarditis
Patients between the ages of 18-65 diagnosed with infective endocarditis according to the Duke criteria
Diagnostic test: Lubricin
Plasma lubricin levels can potentially serve as a biomarker in situations like endocardial injury and infection.
Patients without infective endocarditis
Patients between the ages of 18-65 without diagnosed with infective endocarditis according to the Duke criteria
Diagnostic test: Lubricin
Plasma lubricin levels can potentially serve as a biomarker in situations like endocardial injury and infection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Valve damage indicative sign in infective endocarditis
Time Frame: through study completion, an average of 2 years
Concentration of Lubricin parameter have a determinative role in patients with infective endocarditis
through study completion, an average of 2 years

Collaborators and Investigators

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

Sponsor

Aydin Adnan Menderes 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 (Estimated)

February 11, 2024

Primary Completion (Estimated)

February 20, 2024

Study Completion (Estimated)

February 20, 2026

Study Registration Dates

First Submitted

October 25, 2023

First Submitted That Met QC Criteria

February 11, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 11, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCT093509350936

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

At the end of the study, the results of the statistical analysis of all collected data will be shared

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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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