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

NCT07209644 | Not Yet Recruiting

• 1 other identifier: Serum Catestatin
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Systemic Sclerosis

Keywords

Systemic sclerosis

Outcome Measures

Primary Outcomes (1)

• change in level of serum catestatin concentration in systemic sclerosis patients compared with healthy controls.

  Quantification of serum catestatin levels using ELISA, directly compared between the two study groups.

  baseline

Study Arms (2)

Systemic Sclerosis Arm

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

Control Arm

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will include 35 patients diagnosed with systemic sclerosis according to the 2013 ACR-EULAR classification criteria and 35 age- and sex-matched healthy controls without autoimmune or cardiovascular diseases. Patients must be over 18 years old, and both genders will be included. Controls will be recruited from hospital staff and volunteers. Exclusion criteria eliminate any confounding factors affecting serum catestatin, including other autoimmune diseases, comorbid cardiovascular conditions unrelated to SSc, diabetes, chronic kidney disease, and obesity.

You may qualify if:

• Patients diagnosed with systemic sclerosis according to 2013 ACR-EULAR classification criteria.
• Age \>18 years.

You may not qualify if:

• Other autoimmune disorders.
• Cardiovascular conditions not linked to systemic sclerosis.
• Comorbidities affecting catestatin metabolism (e.g., diabetes, chronic kidney disease, obesity).

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident at the Rheumatology, Rehabilitation and Physical Medicine department

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: October 7, 2025
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 7, 2025

Record last verified: 2025-09