Study of clonal hematopoiesis of undetermined potential (CHIP) and proinflammatory biomarkers in patients with early in-stent occlusion after recanalizatio
- Conditions
- I70.2Atherosclerosis of arteries of extremities
- Registration Number
- DRKS00034395
- Lead Sponsor
- niversitätsklinikum Augsburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 25
Competent patients who have been informed about the study both in writing and orally and have agreed to participate.
Women and men with PAOD stages IIb-IV who are undergoing either a first intervention with stent placement or a reintervention for stent occlusion.
Evidence of high-grade peripheral arterial stenoses demonstrated by duplex ultrasound (FKDS), CT, or MRI.
Patients with a tumor diagnosis
Patients with a known coagulation disorder
Patients under guardianship
Patients with a contraindication to the recommended antiplatelet therapy
Patients who have prematurely discontinued or paused the recommended antiplatelet therapy
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Frequency of CHIP Mutations in aarly stent occlusion ( <1year):<br>Determine if CHIP mutations (e.g., TET2 gene) are more frequent in patients experiencing early re-occlusion (within 1 year) after peripheral recanalization with stent implantation compared to a control group with long-term successful outcomes.<br><br>2. Correlation between CHIP mutations and early stent occlusions:<br>Evaluate the correlation between the presence of CHIP mutations and early re-occlusions (within 1 year) after stent implantation in patients with peripheral arterial occlusive disease (PAOD)
- Secondary Outcome Measures
Name Time Method 1. Increased/decreased levels of certain cytokines<br> Assess if there is a biological correlate in terms of increased or decreased concentrations of specific cytokines associated with early re-occlusions (within 1 year) after peripheral recanalization with stent implantation.<br><br>2. Cytokine Concentrations in CHIP carriers vs. Non-CHIP carriers:<br>Compare the plasma concentrations of cytokines between CHIP carriers and non-CHIP carriers, both with and without stent occlusion.