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

Behçet's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06296004
• Other study ID #: CAPILLAROSCOPY behcet disease
• Status: Not yet recruiting
• Start date: March 1, 2024
• Est. completion date: April 1, 2025

Study information

• Verified date: February 2024
• Source: Assiut University
• Contact: Eman Hamed, professor doctor
• Phone: 01066643425
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: April 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 60 Years

Eligibility

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. -

Related Conditions & MeSH terms

• Behcet Syndrome
• Behçet's Disease

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (19)

• Onan, D., Uysal, P., Hayran, Y., Sahin Dalgiç, G., Hayran, M., Artüz, F. & Yalçin, B. (2019) Dermatoscopic Assessment of Nailfold Capillary Abnormalities in Behçet's Disease and Correlation of the Findings with Disease Activity and Severity. Dermatologica Sinica, 37, 40-45.

Alibaz-Oner F, Direskeneli H. Assessment of venous wall thickness with Doppler ultrasonography may be a diagnostic tool for Behcet's disease. Int J Rheum Dis. 2019 May;22(5):767-768. doi: 10.1111/1756-185X.13574. No abstract available. — View Citation

Alibaz-Oner F, Ergelen R, Yildiz Y, Aldag M, Yazici A, Cefle A, Koc E, Artim Esen B, Mumcu G, Ergun T, Direskeneli H. Femoral vein wall thickness measurement: A new diagnostic tool for Behcet's disease. Rheumatology (Oxford). 2021 Jan 5;60(1):288-296. doi: 10.1093/rheumatology/keaa264. — View Citation

Alten F, Heiduschka P, Clemens CR, Eter N. Exploring choriocapillaris under reticular pseudodrusen using OCT-Angiography. Graefes Arch Clin Exp Ophthalmol. 2016 Nov;254(11):2165-2173. doi: 10.1007/s00417-016-3375-1. Epub 2016 May 18. — View Citation

Bhakta BB, Brennan P, James TE, Chamberlain MA, Noble BA, Silman AJ. Behcet's disease: evaluation of a new instrument to measure clinical activity. Rheumatology (Oxford). 1999 Aug;38(8):728-33. doi: 10.1093/rheumatology/38.8.728. — View Citation

Bonini Filho MA, Adhi M, de Carlo TE, Ferrara D, Baumal CR, Witkin AJ, Reichel E, Kuehlewein L, Sadda SR, Sarraf D, Duker JS, Waheed NK. OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY IN RETINAL ARTERY OCCLUSION. Retina. 2015 Nov;35(11):2339-46. doi: 10.1097/IAE.0000000000000850. — View Citation

Cheng D, Shen M, Zhuang X, Lin D, Dai M, Chen S, Lu F, Wang Y. Inner Retinal Microvasculature Damage Correlates With Outer Retinal Disruption During Remission in Behcet's Posterior Uveitis by Optical Coherence Tomography Angiography. Invest Ophthalmol Vis Sci. 2018 Mar 1;59(3):1295-1304. doi: 10.1167/iovs.17-23113. — View Citation

Chojnowski MM, Felis-Giemza A, Olesinska M. Capillaroscopy - a role in modern rheumatology. Reumatologia. 2016;54(2):67-72. doi: 10.5114/reum.2016.60215. Epub 2016 Jun 3. — View Citation

de Carlo TE, Romano A, Waheed NK, Duker JS. A review of optical coherence tomography angiography (OCTA). Int J Retina Vitreous. 2015 Apr 15;1:5. doi: 10.1186/s40942-015-0005-8. eCollection 2015. — View Citation

International Team for the Revision of the International Criteria for Behcet's Disease (ITR-ICBD). The International Criteria for Behcet's Disease (ICBD): a collaborative study of 27 countries on the sensitivity and specificity of the new criteria. J Eur Acad Dermatol Venereol. 2014 Mar;28(3):338-47. doi: 10.1111/jdv.12107. Epub 2013 Feb 26. — View Citation

Khairallah M, Abroug N, Khochtali S, Mahmoud A, Jelliti B, Coscas G, Lupidi M, Kahloun R, Ben Yahia S. OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY IN PATIENTS WITH BEHCET UVEITIS. Retina. 2017 Sep;37(9):1678-1691. doi: 10.1097/IAE.0000000000001418. — View Citation

Lupidi M, Cerquaglia A, Chhablani J, Fiore T, Singh SR, Cardillo Piccolino F, Corbucci R, Coscas F, Coscas G, Cagini C. Optical coherence tomography angiography in age-related macular degeneration: The game changer. Eur J Ophthalmol. 2018 Jul;28(4):349-357. doi: 10.1177/1120672118766807. Epub 2018 Apr 6. — View Citation

Samara WA, Shahlaee A, Adam MK, Khan MA, Chiang A, Maguire JI, Hsu J, Ho AC. Quantification of Diabetic Macular Ischemia Using Optical Coherence Tomography Angiography and Its Relationship with Visual Acuity. Ophthalmology. 2017 Feb;124(2):235-244. doi: 10.1016/j.ophtha.2016.10.008. Epub 2016 Nov 23. — View Citation

Samara WA, Shahlaee A, Sridhar J, Khan MA, Ho AC, Hsu J. Quantitative Optical Coherence Tomography Angiography Features and Visual Function in Eyes With Branch Retinal Vein Occlusion. Am J Ophthalmol. 2016 Jun;166:76-83. doi: 10.1016/j.ajo.2016.03.033. Epub 2016 Mar 31. — View Citation

Sambhav K, Grover S, Chalam KV. The application of optical coherence tomography angiography in retinal diseases. Surv Ophthalmol. 2017 Nov-Dec;62(6):838-866. doi: 10.1016/j.survophthal.2017.05.006. Epub 2017 Jun 1. — View Citation

Somkijrungroj T, Vongkulsiri S, Kongwattananon W, Chotcomwongse P, Luangpitakchumpol S, Jaisuekul K. Assessment of Vascular Change Using Swept-Source Optical Coherence Tomography Angiography: A New Theory Explains Central Visual Loss in Behcet's Disease. J Ophthalmol. 2017;2017:2180723. doi: 10.1155/2017/2180723. Epub 2017 May 9. — View Citation

Spaide RF, Fujimoto JG, Waheed NK, Sadda SR, Staurenghi G. Optical coherence tomography angiography. Prog Retin Eye Res. 2018 May;64:1-55. doi: 10.1016/j.preteyeres.2017.11.003. Epub 2017 Dec 8. — View Citation

Tugal-Tutkun I, Ozdal PC, Oray M, Onal S. Review for Diagnostics of the Year: Multimodal Imaging in Behcet Uveitis. Ocul Immunol Inflamm. 2017 Feb;25(1):7-19. doi: 10.1080/09273948.2016.1205100. Epub 2016 Aug 19. — View Citation

Yilmaz PT, Ozdemir EY, Alp MN. Optical coherence tomography angiography findings in patients with ocular and non-ocular Behcet disease. Arq Bras Oftalmol. 2021 May-Jun;84(3):235-240. doi: 10.5935/0004-2749.20210031. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measuring parameter of Nail Fold Capillaroscopy in behcet disease	using previous parameters in diagnosis of vascular affection in behcet disease	1 year
Primary	measuring parameter of Optical Coherence Tomography Angiography in behcet disease	using previous parameters in diagnosis of vascular affection in behcet disease	1 year
Primary	measuring parameter of Femoral Vein Wall Thickness in behcet disease	using previous parameters in diagnosis of vascular affection in behcet disease	1year
Secondary	relation between Nail Fold Capillaroscopy and activity of behcet disease	using previous parameters in measuring disease activity	1 years
Secondary	relation between Optical Coherence Tomography Angiography and activity of behcet disease	using previous parameters in measuring disease activity	1 year
Secondary	relation between Femoral Vein Wall Thickness and activity of behcet disease	using previous parameters in measuring disease activity	1 year