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Enrolling by invitationNCT06266741Updated Feb 20, 2024

The Predictive Value of Lubricin in Patients With Infective Endocarditis

An observational study in Infective Endocarditis, sponsored by Aydin Adnan Menderes University. Enrolling by invitation at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-02-20.

Sponsored by Aydin Adnan Menderes University · Observational

From the registry’s dates

  • Primary completion was expected by Feb 2024, 2 years 8 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 65 Years
Sex
All
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Study 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

Read the 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.

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Conditions studied

  • Infective Endocarditis

Keywords

  • Infective endocarditis
  • Lubricin
  • Glycoprotein
  • Procalcitonin
03

In context

Endocarditis

173 studies on the registry are indexed under Endocarditis; 57 are open to participants now.

This study's planned enrollment of 60 is below the median of 225 across 82 observational studies indexed under Endocarditis.

Browse Endocarditis studies →

Lead sponsor

Aydin Adnan Menderes University is the lead sponsor of 241 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • The patient being pregnant
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testLubricin

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

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What researchers measure

Primary outcomes

  1. Valve damage indicative sign in infective endocarditis

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

    Time frame: through study completion, an average of 2 years

07

Study locations

1 site
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References and documents

Publications

  • 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 Dec 1;44(45):4780. doi: 10.1093/eurheartj/ehad625. Eur Heart J. 2024 Jan 1;45(1):56. doi: 10.1093/eurheartj/ehad776. Eur Heart J. 2025 Mar 13;46(11):1082. doi: 10.1093/eurheartj/ehae877. PubMed 37622656 ↗
  • 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. PubMed 31941729 ↗
  • 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. PubMed 27582414 ↗
  • 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. PubMed 31733682 ↗
  • 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. PubMed 34459483 ↗

Individual participant data

Plan to share: Yes — At the end of the study, the results of the statistical analysis of all collected data will be shared

Supporting information: Study protocol, Statistical analysis plan

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2024; primary completion for Feb 2024, 0 months later.

Of 36 observational studies under Endocarditis, half reached primary completion within 62 months of starting (the median), counting those still running; a quarter within 36. This study's planned 0 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 25, 2023
First posted
Feb 20, 2024
StartEst.
Feb 11, 2024
Primary completionEst.
Feb 20, 2024
CompletionEst.
Feb 20, 2026
Last update
Feb 20, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06266741
Responsible party
Sevil Gulastı (Assistant Professor, Aydin Adnan Menderes University) — Principal investigator
First posted
Feb 20, 2024
Start date
Feb 11, 2024 (estimated)
Primary completion
Feb 20, 2024 (estimated)
Completion
Feb 20, 2026 (estimated)
Last update
Feb 20, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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