Serum Elafin and Vascular Affection in Behcet Disease

NCT ID: NCT06272929

Last Updated: 2024-02-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2025-04-01

Brief 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.

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 .

Conditions

Behcet Disease and Vascular Affection

Study Design

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

Study Groups

45 patients with behcet disease

doppler ultrasound

Intervention Type: DEVICE

doppler US

45 healthy participants

doppler ultrasound

Intervention Type: DEVICE

doppler US

Interventions

doppler ultrasound

doppler US

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Lobna Amer Araby Ahmed

Assiut

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Lobna Amer, MD

Role: CONTACT

lobnaamer20@gmail.com

01019313530

References

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.

Reference Type: BACKGROUND

PMID: 21124084 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37822392 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34531393 (View on PubMed)

Other Identifiers

behcet and vascular

Identifier Type: -

Identifier Source: org_study_id