Relation Between Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness in Behçet's Disease Relation Between Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness in Behçet's Disease

February 28, 2024 updated by: Elzahraa Awny Fathy, Assiut University

Relation Between Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness in Behçet's Disease

Relation between Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness in Behçet's Disease

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Behçet disease (BD) is a multisystemic, autoinflammatory, chronic illness that is quite common in the nations along the ancient Silk Road. It is characterized by immune-mediated vasculitis, which can affect blood vessels of any size throughout all organ systems Vascular involvement, is one of the more serious symptoms of BD, which is considered to have a poor prognostic value. The majority of research on vascular involvement in BD focuses on large vessel involvement; however, less research discusses microvascular damage. Capillaroscopy is a non-invasive diagnostic method used to assess small vessels in the microcirculation Furthermore, ocular inflammation is the most prevalent form affecting more than 70% of Behçet diseased patients in the form of relapsing, remitting uveitis Fluorescein angiography is currently the gold standard for documenting and tracking posterior segment involvement in BD because it can easily detects retinal ischemia, macular edema, and retinal vascular leakage . Nevertheless, this process is invasive, necessitating the injection of an external dye, and its depth resolution is restricted Recently, optical coherence tomography angiography (OCT-A) has emerged as a highly effective method for obtaining high resolution en face images of the choroidal and retinal microvasculature, as well as for analyzing changes in the choriocapillaris, deep capillary plexus, and superficial capillary plexus independently . OCT-A allows for the assessment of both qualitative and quantitative alterations within the retinal microvasculature. Few research have looked into the use of OCT-A in Behçet uveitis, despite the fact that its role in the evaluation of retinal vascular diseases, such as diabetic retinopathy, retinal venous occlusions, retinal arterial occlusions, and age-related macular degeneration, has been thoroughly examined in the recent literature It has recently been proposed that venous wall thickness (VWT), measured by Doppler ultrasonography (US), can serve as an indirect sonographic marker for the extent of vascular end organ damage, including venous illness. Increased VWT, particularly in the femoral and popliteal veins, has been shown in numerous investigations to be a highly significant clinical characteristic in BD However, whether US findings are correlated with vascular involvement in BD is still unknown. It has been determined that the most suitable site to evaluate VWT using US is the common femoral vein (CFV). A sensitivity of 81-22% and a specificity of 78.4-81.1.1% have been reported for the VWT cut-off point of ≥0.5 mm in the diagnosis of BD. It has therefore been suggested as an efficient and non-invasive method for diagnosing BD

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Eman Hamed, professor doctor
  • Phone Number: 01066643425

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

The study will include 80 participants:

Group 1: 40 patients with who fulfilling the criteria for the diagnosis by International Team for the Revision of the International Criteria for Bechet's Disease (Disease et al., 2014).

. Group 2: 40 healthy matched controls.

Description

Inclusion Criteria:

  1. Adult BD patients who fulfilling the criteria for the diagnosis by International Team for the Revision of the International Criteria for Bechet's Disease .
  2. Accept to participate in the current study -

Exclusion Criteria:

  1. Individuals with other autoimmune diseases (rheumatoid arthritis dermatomyositis, scleroderma, mixed connective tissue disease).
  2. Patients with high myopia or media opacities preventing high-quality imaging like cataract and cornea guttata, vitreoretinal disease, previous retinal surgery, macular edema, glaucoma or neurological disease.
  3. Patients with other comorbidities as diabetes, hypertension were excluded from the study.

  4. Refused to participate in the current study.

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
adult patient with Behçet's Disease
. Adult BD patients who fulfilling the criteria for the diagnosis by International Team for the Revision of the International Criteria for Bechet's Disease .
Device: Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness by U.S

Complete blood count (CBC) Erythrocyte sedimentation rate (ESR) measured by standard westergren method (mm/h).

Serum C-reactive protein (CRP) Liver function tests: aspartate transaminase (AST), alanine transaminase (ALT), serum albumin, serum bilirubin.

Renal function tests: serum creatinine and blood urea. Complete urine analysis.

Optical coherence tomography angiography (OCTA): . Bilateral common femoral vein (CFV) Doppler US
healthy subjects
apparently healthy subjects
Device: Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness by U.S

Complete blood count (CBC) Erythrocyte sedimentation rate (ESR) measured by standard westergren method (mm/h).

Serum C-reactive protein (CRP) Liver function tests: aspartate transaminase (AST), alanine transaminase (ALT), serum albumin, serum bilirubin.

Renal function tests: serum creatinine and blood urea. Complete urine analysis.

Optical coherence tomography angiography (OCTA): . Bilateral common femoral vein (CFV) Doppler US

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measuring parameter of Nail Fold Capillaroscopy in behcet disease
Time Frame: 1 year
using previous parameters in diagnosis of vascular affection in behcet disease
1 year
measuring parameter of Optical Coherence Tomography Angiography in behcet disease
Time Frame: 1 year
using previous parameters in diagnosis of vascular affection in behcet disease
1 year
measuring parameter of Femoral Vein Wall Thickness in behcet disease
Time Frame: 1year
using previous parameters in diagnosis of vascular affection in behcet disease
1year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
relation between Nail Fold Capillaroscopy and activity of behcet disease
Time Frame: 1 years
using previous parameters in measuring disease activity
1 years
relation between Optical Coherence Tomography Angiography and activity of behcet disease
Time Frame: 1 year
using previous parameters in measuring disease activity
1 year
relation between Femoral Vein Wall Thickness and activity of behcet disease
Time Frame: 1 year
using previous parameters in measuring disease activity
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

February 21, 2024

First Submitted That Met QC Criteria

February 28, 2024

First Posted (Estimated)

March 6, 2024

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAPILLAROSCOPY behcet disease

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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