Clinical trial NCT00668473: Angiogenic/Angiostatic Mediators in Patients With Systemic Sclerosis
Official title: Endostatin and Other Angiogenic/Angiostatic Mediators in Patients With Systemic Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Sclerosis
Keywords: systemic sclerosis angiogenesis
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2008-04-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Attendees of a tertiary care clinic

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Level of endostatin in skin and serum
timeFrame: At time of of biopsy and blood draw
Secondary outcomes:
measure: Level of JAM-A in skin and serum
timeFrame: At time of blood draw and skin biopsy
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Hospitals
state: Michigan
Study officials:
affiliation: University of Michigan
name: Kristine Phillips, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: James R Seibold, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Alisa E Koch, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Julie A Konkle, BSN
role: STUDY_DIRECTOR
References: