Clinical trial NCT06266741: The Predictive Value of Lubricin in Patients With Infective Endocarditis
Official title: The Predictive Value of Lubricin in Patients With Infective Endocarditis
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Infective Endocarditis
Keywords: Infective endocarditis
Lubricin
Glycoprotein
Procalcitonin
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Valve damage indicative sign in infective endocarditis
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Sevil Gulasti
state: Zafer
Study officials:
References:
citation: 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.
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.
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.
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.
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.