Nailfold Capillaroscopic Pattern Changes and Its Correlation with Interstitial Lung Disease (ILD) in Systemic Sclerosis (SSc) Patients.

NCT ID: NCT06579651

Last Updated: 2024-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-31

Study Completion Date

2025-11-30

Brief Summary

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Detection of different pattern of nail fold capillary changes in SSc patients. Correlation of nail fold capillary changes in SSc patients with ILD.

Detailed Description

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SSc is a connective tissue disease characterized by early microvascular damage and dysfunction and immune system activation, as well as progressive fibrosis in the skin and internal organs.

Nailfold videocapillaroscopy (NVC) is the validated technique to assess SSc microvascular damage and is useful for the early diagnosis and follow-up of SSc micro- angiopathy.

Several studies have demonstrated correlations between microvascular damage extent and the severity of internal organ involvement, showing that NVC abnormalities correlate with disease activity and severity and may be also predictive for disease worsening. Furthermore, successful treatments have been shown to reduce NVC abnormalities in SSc cases, and these findings support the importance of NVC in monitoring SSc patients and also suggest its possible role as an outcome measure for microangiopathy in clinical trials.

Three different NVC patterns of microvascular damage have been described (\"early\" , \"active\" , \"late\" ).

Conditions

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Systemic Sclerosis (SSc)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Nailfold videocapillaroscopy (NVC)

Nailfold videocapillaroscopy (NVC) is the validated technique to assess SSc microvascular damage and is useful for the early diagnosis and follow-up of SSc micro- angiopathy.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adult SSc Patients

Exclusion Criteria

\- 1-SSc patients aged less than 18 years old. 2-Individuals with other autoimmune diseases (rheumatoid arthritis, dermatomyositis, connective tissue disease).

3-Congestive heart failure and presence of clubbing. 4-history of smoking. 5-Patients unable to co-operate for nail fold capillaroscopic examination.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mennatullah Salaheldin

Mennatullah Salaheldin Mohamed

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Mennatullah Salaheldin

Role: CONTACT

Phone: +201010616746

Email: [email protected]

Other Identifiers

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NVC in SSc patients

Identifier Type: -

Identifier Source: org_study_id