NCT06266741

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

First Submitted

Initial submission to the registry

October 25, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

February 11, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2026

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

9 days

First QC Date

October 25, 2023

Last Update Submit

February 11, 2024

Conditions

Keywords

Infective endocarditisLubricinGlycoproteinProcalcitonin

Outcome Measures

Primary Outcomes (1)

  • Valve damage indicative sign in infective endocarditis

    Concentration of Lubricin parameter have a determinative role in patients with infective endocarditis

    through study completion, an average of 2 years

Study Arms (2)

Patients with infective endocarditis

Patients between the ages of 18-65 diagnosed with infective endocarditis according to the Duke criteria

Diagnostic Test: Lubricin

Patients without infective endocarditis

Patients between the ages of 18-65 without diagnosed with infective endocarditis according to the Duke criteria

Diagnostic Test: Lubricin

Interventions

LubricinDIAGNOSTIC_TEST

Plasma lubricin levels can potentially serve as a biomarker in situations like endocardial injury and infection.

Patients with infective endocarditisPatients without infective endocarditis

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • \- The patient being pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sevil Gulasti

Aydin, Zafer, 09010, Turkey (Türkiye)

Location

Related Publications (5)

  • Delgado V, Ajmone Marsan N, de Waha S, Bonaros N, Brida M, Burri H, Caselli S, Doenst T, Ederhy S, Erba PA, Foldager D, Fosbol EL, Kovac J, Mestres CA, Miller OI, Miro JM, Pazdernik M, Pizzi MN, Quintana E, Rasmussen TB, Ristic AD, Rodes-Cabau J, Sionis A, Zuhlke LJ, Borger MA; ESC Scientific Document Group. 2023 ESC Guidelines for the management of endocarditis. Eur Heart J. 2023 Oct 14;44(39):3948-4042. doi: 10.1093/eurheartj/ehad193. No abstract available.

    PMID: 37622656BACKGROUND
  • Rajani R, Klein JL. Infective endocarditis: A contemporary update. Clin Med (Lond). 2020 Jan;20(1):31-35. doi: 10.7861/clinmed.cme.20.1.1.

    PMID: 31941729BACKGROUND
  • Holland TL, Baddour LM, Bayer AS, Hoen B, Miro JM, Fowler VG Jr. Infective endocarditis. Nat Rev Dis Primers. 2016 Sep 1;2:16059. doi: 10.1038/nrdp.2016.59.

    PMID: 27582414BACKGROUND
  • Richendrfer H, Jay GD. Lubricin as a Therapeutic and Potential Biomarker in Sepsis. Crit Care Clin. 2020 Jan;36(1):55-67. doi: 10.1016/j.ccc.2019.08.005. Epub 2019 Oct 21.

    PMID: 31733682BACKGROUND
  • Solakyildirim K, Li Y, Bayer AS, Sullam PM, Xiong YQ, Lebrilla CB, Bensing BA. Proteoglycan 4 (lubricin) is a highly sialylated glycoprotein associated with cardiac valve damage in animal models of infective endocarditis. Glycobiology. 2021 Dec 18;31(11):1582-1595. doi: 10.1093/glycob/cwab095.

    PMID: 34459483BACKGROUND

MeSH Terms

Conditions

EndocarditisJacobs syndrome

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 25, 2023

First Posted

February 20, 2024

Study Start

February 11, 2024

Primary Completion

February 20, 2024

Study Completion

February 20, 2026

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP

Locations