Serum Elafin and Vascular Affection in Behcet Disease

NCT06272929 — Unknown, 90 participants, Assiut University

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Serum Elafin: A Biomarker in Behcet Disease and Its Relation to Vascular Involvement and Disease Activity

RegistryNCT06272929
StatusUnknown
Study typeObservational
Enrollment90 (Estimated)
SponsorAssiut University (Other)
ConditionsBehcet Disease and Vascular Affection
Interventionsdoppler ultrasound (Device)
Datesstart 2024-03-01 (estimated), primary completion 2025-03-01 (estimated), completion 2025-04-01 (estimated), first posted 2024-02-22, last updated 2024-02-22

Related Papers Related Patents Related Grants Related Experts
All trials for Behcet Disease and Vascular Affection All trials of doppler ultrasound

-Summary

To measure the level of serum elafin in patients with BD. To assess the relation between serum elafin levels and disease activity. To evaluate the vascular complications in BD and determine their relationship with disease activity.

To assess the correlation between serum elafin and vascular affection and their relation with disease activity.

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+Detailed description

Behçet's disease (BD) is a chronic, multisystemic, inflammatory disease characterized by recurrent oral and genital ulcers and multiple systemic involvements. Elafin is a serine protease inhibitor produced mainly by epithelial cells. Its expression is upregulated by proinflammatory cytokines such as IL-1β and TNF-α that are potent stimulants of neutrophil activation, it counteracts the destructive effects of neutrophil elastase .Interestingly, previous reports documented the role of serum elafin in the pathogenesis of BD.In fact, vascular complications may be one of the earliest manifestations leading to the diagnosis of BD. There is no reliable tool to identify vascular wall inflammation in BD, except for detecting intravascular thrombosis with ultrasonography (US). Previous studies investigated arterial vessel wall thickness with US (mostly in carotid arteries) in BD . Venous wall inflammation presents with deep vein thrombosis and superficial thrombophlebitis . It was stated that lower extremity vein wall thickness (VWTs)was increased in BD patients independently of vascular activity and important in the diagnosis . However, studies in the literature evaluated only lower extremity VWTs, whereas the relationship of VWT with disease activity has not been emphasized .

+Arms and interventions

ArmTypeInterventionsDescription
45 patients with behcet diseaseDevice: doppler ultrasound
45 healthy participantsDevice: doppler ultrasound
  • doppler ultrasound (Device): doppler US

+Outcome measures

Primary outcomes

  • Measuring the level of serum Elafin in patients with BD in comparison to healthy participants. [within one year]: Measuring the level of serum Elafin in patients with BD in comparison to healthy participants.

+Eligibility

Sex: All, ages: 20 Years to 45 Years

Inclusion Criteria:

Patients diagnosed as BD. Age of all participants (20-45) years.

Exclusion Criteria:

Age <20 or >45 years. Other autoimmune diseases. Cardiovascular diseases (heart failure, myocardial ischemia). Possible related risk factors (e.g. diabetes, dyslipidemia, smoking). chronic conditions (e.g. chronic kidney disease, malignancy, autoimmune diseases).

+Publications

  • Calamia KT, Schirmer M, Melikoglu M. Major vessel involvement in Behcet's disease: an update. Curr Opin Rheumatol. 2011 Jan;23(1):24-31. doi: 10.1097/BOR.0b013e3283410088. PMID 21124084
  • Kutlay A, Kose AA. Serum Elafin as a Potential Marker of Disease Activity in Behcet's Disease. Indian J Dermatol. 2023 Jul-Aug;68(4):372-376. doi: 10.4103/ijd.ijd_913_22. PMID 37822392
  • Yazici Y, Hatemi G, Bodaghi B, Cheon JH, Suzuki N, Ambrose N, Yazici H. Behcet syndrome. Nat Rev Dis Primers. 2021 Sep 16;7(1):67. doi: 10.1038/s41572-021-00301-1. PMID 34531393