Angiogenic/Angiostatic Mediators in Patients With Systemic Sclerosis

Systemic Sclerosis Clinical Trial

Official title:

Endostatin and Other Angiogenic/Angiostatic Mediators in Patients With Systemic Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00668473
• Other study ID #: HUM00011196
• Status: Completed
• Phase: N/A
• First received: April 25, 2008
• Last updated: October 24, 2016
• Start date: May 2007
• Est. completion date: January 2012

Study information

• Verified date: October 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

We propose to examine several angiogenic/angiostatic mediators in the skin and serum of subjects with SSc and compare it to levels found in the skin and serum of healthy subjects.

Description:

Systemic sclerosis (SSc) is a connective tissue disease that is characterized by fibrosis of the skin and internal organs. One of the earliest pathologic changes in patients with SSc is damage to the blood vessels. Many abnormalities have been found in the inner layer of the blood vessel, the enothelial tissue. It is known that there are mediators in the blood and tissues of the body that affect the endothelial tissue. These are called angiogenic (promote blood vessel formation) and angiostatic (inhibit blood vessel formation) mediators. Many of these mediators have been examined in the peripheral blood of patients with SSc, but fewer of these mediators have been examined at the site of action, in the tissue near the microvasculature. We hypothesize that there are differences in the levels of angiogenic/angiostatic mediators between healthy subjects and subjects with SSc. In addition, we propose that there are differences at skin sites that have varying levels of involvement with SSc of these angiogenic/angiostatic factors in subjects with SSc.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2012
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Meet American College of Rheumatology criteria for systemic sclerosis

2. Subjects with systemic sclerosis must have involvement proximal to the knee or elbow, excluding the face

3. Persons with no chronic health conditions

Exclusion Criteria:

1. Persons with systemic sclerosis as a result of being exposed to chemicals or drugs that can cause a sceroderma-like illness

2. Persons with autoimmune diseases other than systemic sclerosis

3. Persons treated with cyclophosphamide in the last 8 weeks

4. Persons with active infections, including but not limited to hepatitis C, hepatitis B, and HIV

5. Persons prone to bleeding because they are treated with medications that thin the blood or have a low platelet count

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Locations

Country	Name	City	State
United States	University of Michigan Hospitals	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of endostatin in skin and serum		At time of of biopsy and blood draw	No
Secondary	Level of JAM-A in skin and serum		At time of blood draw and skin biopsy	No