The Predictive Value of Lubricin in Patients With Infective Endocarditis

NCT ID: NCT06266741

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-11
• Study Completion Date: 2026-02-20

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

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.

Conditions

Infective Endocarditis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with infective endocarditis

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

Lubricin

Intervention Type: DIAGNOSTIC_TEST

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

Lubricin

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Lubricin

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aydin Adnan Menderes University

OTHER

Sponsor Role: lead

Responsible Party

Sevil Gulastı

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sevil Gulasti

Aydin, Zafer, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 37622656 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31941729 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27582414 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31733682 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34459483 (View on PubMed)

Other Identifiers

NCT093509350936

Identifier Type: -

Identifier Source: org_study_id