NFC Changes in SLE Patients and Its Correlation With Anti-U1RNPAntibodies and Disease Activity

NCT05106998 | Unknown FDA Device

• 1 other identifier: NFC in SLE , Anti-U1RNP Ab
• Study Type: observational
• Target: 85
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.Detection of different pattern of nail fold capillary changes in SLE patient.
2. 2.Correlation of nail fold capillary changes in SLE patients and Anti-U1RNP antibodies.
3. 3.Correlation of nail fold capillary changes with SLE disease activity.
4. 4.Frequency of nail fold capillary changes in SLE patients

Conditions

System Lupus Erythematosus

Keywords

nailfold capillaroscopy; anti-U1RNP antibodies; Disease activity

Outcome Measures

Primary Outcomes (1)

• Frequency of nail fold capillary changes in SLE patient.

  capillary changes on nailfold capillaroscopy examination for SLE patients

  baseline

Secondary Outcomes (3)

• 1- Detection of patterns of nailfold capillary changes in SLE .

  baseline

• 2-Correlation of nailfold capillary changes in SLE patient and Anti-U1RNP antibodies.

  baseline

• 3-Correlation of nailfold capillary changes with SLE disease activity .

  baseline

Interventions

nailfold capillaroscopy DEVICE

Nailfold capillaroscopy (NFC) is a non-invasive easily repeatable technique and the best method for morphological analysis of nutritional capillaries in the nailfold area

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

: Collected from Rheumatology, Rehabilitation and Physical Medicine Department, inpatient and outpatient clinics , Assiut University Hospital

You may qualify if:

• Adult SLE Patients who fulfilled the 2012 systemic lupus international collaborating clinics (SLICC) criteria

You may not qualify if:

• SLE patient aged less than 18 yeares old.
• Individuals with other autoimmune diseases (rheumatoid arthritis dermatomyositis, scleroderma, mixed connective tissue disease).
• Congestive cardic failure and presence of clupping.
• Coexisting diabetes mellitus.
• history of smoking.
• Patients unable to co-operate for nailfold capillaroscopic examination

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• Zhao T, Lin FA, Chen HP. Pattern of Nailfold Capillaroscopy in Patients With Systemic Lupus Erythematosus. Arch Rheumatol. 2020 Apr 20;35(4):568-574. doi: 10.46497/ArchRheumatol.2020.7763. eCollection 2020 Dec.

  PMID: 33758813 BACKGROUND

• Chebbi PP, Goel R, Ramya J, Gowri M, Herrick A, Danda D. Nailfold capillaroscopy changes associated with anti-RNP antibodies in systemic lupus erythematosus. Rheumatol Int. 2022 Aug;42(8):1355-1361. doi: 10.1007/s00296-021-04894-4. Epub 2021 Jun 2.

  PMID: 34076720 BACKGROUND

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Microscopic Angioscopy

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Intravital Microscopy; Microscopy; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Cardiovascular; Investigative Techniques

Central Study Contacts

Amera I. Abdel-Ghany, Dr

CONTACT

01003139319; amera_i95@yahoo.com

Yasmine S. Makarem, Dr

CONTACT

01002929015; Yasmine.saad@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor at Physical medicine ,Rheumatology and Rehabilitation department

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 4, 2021
• Study Start: March 1, 2022
• Primary Completion: November 1, 2022
• Study Completion: June 1, 2023
• Last Updated: December 14, 2021

Record last verified: 2021-12