Analysis of time-dependent changes in immune cell distribution and expression of immunological cytokines in patients with different stages of peripheral arterial disease (PAD)

Recruiting

Conditions: I70.2
Atherosclerosis of arteries of extremities

Registration Number: DRKS00032916

Lead Sponsor: niversitätsklinikum Augsburg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

• Legally competent patients who have been informed about the study in writing and verbally and have agreed to participate.
• Women and men over 18 years of age who have been diagnosed with PAD in Stage IIb, III or IV according to Fontaine using clinical examination, ABI measurement and, if necessary, appropriate imaging (duplex sonography, CTA; MRA). The examinations are carried out exclusively for the purpose of medical treatment.
• Competent healthy women and men over 18 years of age who agreed to participate in this study as a healthy control group. The assignment as a control group is based on the lack of symptoms. No clinical examinations are carried out to rule out an illness.

Exclusion Criteria

• Patients with tumor diagnosis
• Bedridden patients, as these patients may suffer from inflammatory processes (e.g. as a result of dekubitus).
• Patients with sepsis criteria or accompanying infection such as urinary tract infection, pneumonia, cellulitis, open wound with signs of infection, etc.
• Immunosuppression or taking immunosuppressive medications
• Patients whose health conditions do not permit blood sampling
• Incompetent patients or subjects
• Overweight subjects with high BMI of 35 or greater

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
• Identification of changes in the amount of monocyte classes, Th-cells and regulatory T cells in the blood of patients with PAD of various stages over a year.<br>• Identification of changes in the concentration of cytokines specific to monocytes, Th-cells and regulatory T cells.<br>• Determination of serum-dependent in vitro differentiation of monocytes into classical M1 or non-classical M2 macrophages.

Secondary Outcome Measures