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

December 10, 2021 updated by: Amera Imam Abdel - Ghany Ahmed, Assiut University

Pattern of Nailfold Capillaroscopy Changes in Systemic Lupus Erythematosus Patients and Its Correlation With Anti-Uridin1-ribonucleoprotein Antibodies and Disease Activity

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Systemic lupus erythematosus is a complex, multi-organ autoimmune disease . The presence of autoantibodies and circulating immune complexes can cause vasculitis and damage the endothelial cells, leading to multiple organ dysfunctions .The clinical manifestations of SLE include muco cutaneous, musculoskeletal system, cardiac, neurological, renal, hematologic, and vascular system involvement . Nail fold capillaroscopy (NFC) is a non-invasive easily repeatable technique and the best method for morphological analysis of nutritional capillaries in the nail fold area . Nail fold capillary changes are very common in patients with SLE. the major NFC pattern that has been reported in SLE patients was non-specific sub-types, followed by normal pattern and scleroderma pattern. In (SLE) patients are reported a large spectrum of antibodies, including the anti-ribonucleoproteins (RNP) antibodies These antibodies were linked to several clinical manifestations and prognostic in patients with SLE. Anti-U1-RNP antibodies are involved in both innate and adaptive immune responses during pathogenesis of connective tissue diseases 12. U1-RNP complex is an intra nuclear protein that converts pre-mRNA to mature RNA and constitutes three specific proteins A, C, and 70 kDa. High titer RNP antibodies are detected in MCTD patients and correlated with Clinical disease activity index and the frequent complication of pulmonary artery hypertension in those patients . It also has been found that NFC may detect subclinical microvascular changes in SLE in the presence of anti-U1-RNP antibodies and may facilitate early preventive therapy for major organ vasculopathy .

Study Type

Observational

Enrollment (Anticipated)

85

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

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of nail fold capillary changes in SLE patient.
Time Frame: baseline
capillary changes on nailfold capillaroscopy examination for SLE patients
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1- Detection of patterns of nailfold capillary changes in SLE .
Time Frame: baseline
to detect different patterns by nailfold capillaroscopy
baseline
2-Correlation of nailfold capillary changes in SLE patient and Anti-U1RNP antibodies.
Time Frame: baseline
relation of Anti U1 RNP antibodies and microvasculature as detected by NFC examination
baseline
3-Correlation of nailfold capillary changes with SLE disease activity .
Time Frame: baseline
relation of SLE disease activity and microvasculature as detected in NFC examination
baseline

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 (Anticipated)

March 1, 2022

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

October 25, 2021

First Submitted That Met QC Criteria

October 25, 2021

First Posted (Actual)

November 4, 2021

Study Record Updates

Last Update Posted (Actual)

December 14, 2021

Last Update Submitted That Met QC Criteria

December 10, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFC in SLE , Anti-U1RNP Ab

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

Yes

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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