Catestatin as a Novel Biomarker for Cardiovascular and Microvascular Involvement in Systemic Sclerosis

NCT ID: NCT07209644

Last Updated: 2025-10-07

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

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-11-01

Study Completion Date

2027-12-01

Brief Summary

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This study investigates the relationship between serum catestatin levels and systemic sclerosis (SSc), with a focus on cardiovascular involvement and microvascular alterations, to determine catestatin's potential as a biomarker of disease activity and severity.

Detailed Description

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Systemic sclerosis is a chronic autoimmune disease characterized by fibrosis, autoimmunity, and vasculopathy, with cardiovascular complications accounting for a significant proportion of morbidity and mortality. Despite advances in diagnostic tools, early identification of high-risk patients remains challenging. Catestatin, a peptide derived from chromogranin A, has recently gained attention as a biomarker with regulatory roles in cardiovascular physiology, including hypertension, endothelial function, and vascular remodeling. This cross-sectional study will assess serum catestatin levels in patients with SSc compared with healthy controls. It aims to correlate these levels with disease activity indices, cardiovascular involvement (using echocardiography, ECG, and blood pressure monitoring), and microvascular abnormalities identified via nailfold capillaroscopy. Findings from this study may establish catestatin as a promising biomarker, paving the way for improved management and cardiovascular risk stratification in SSc patients.

Conditions

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Systemic Sclerosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Systemic Sclerosis Arm

Patients with systemic sclerosis (n=35), assessed for disease activity, catestatin levels, cardiovascular involvement, and microvascular changes.

No interventions assigned to this group

Control Arm

Healthy controls (n=35), evaluated for serum catestatin levels to provide a baseline reference.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with systemic sclerosis according to 2013 ACR-EULAR classification criteria.

Age \>18 years.

Exclusion Criteria

* Other autoimmune disorders.

Cardiovascular conditions not linked to systemic sclerosis.

Comorbidities affecting catestatin metabolism (e.g., diabetes, chronic kidney disease, obesity).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Esraa awwad abdoh radwan

resident at the Rheumatology, Rehabilitation and Physical Medicine department

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Serum Catestatin

Identifier Type: -

Identifier Source: org_study_id

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