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NCT06266741 Clinical Trial

The Predictive Value of Lubricin in Patients With Infective Endocarditis

Infective Endocarditis Clinical Trial

Official title:
The Predictive Value of Lubricin in Patients With Infective Endocarditis

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT06266741
Other study ID # NCT093509350936
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date February 11, 2024
Est. completion date February 20, 2026

Study information
Verified date February 2024
Source Aydin Adnan Menderes University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 60
Est. completion date February 20, 2026
Est. primary completion date February 20, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Lubricin
Plasma lubricin levels can potentially serve as a biomarker in situations like endocardial injury and infection.

Locations
Country Name City State
Turkey Sevil Gulasti Aydin Zafer

Sponsors (1)
Lead Sponsor Collaborator
Aydin Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

References & 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. Erratum In: Eur Heart J. 2023 Sep 20;: Eur Heart J. 2024 Jan 1;45(1):56. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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