CXCR2 Leucocyte Expression Level as a Predictive Factor of Coronary Artery Calcification Progression in Advanced Chronic Kidney Disease Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- variation from baseline of CXCR2 expression
研究概览
简要总结
Chronic kidney disease (CKD) is associated with the development of coronary arteries calcifications (CAC) and increased cardiovascular mortality. Previously, the investigators demonstrated that interleukin 8 (IL-8) plays a role in the calcification process, and that blockade of its receptor, CXCR2 reduces cardiovascular calcifications. The investigators hypothesize that leucocytes expressing CXCR2 may contribute to the development and progression of CAC in CKD patients. Identifying CKD patients with a high calcification phenotype and therapeutic targets to prevent cardiovascular calcifications is essential. Advanced CKD patients (stages IV and V) will undergo analysis of CXCR2 expression from neutrophils and monocytes at inclusion by flow cytometry, followed by non-contrast thoracic CT scans at inclusion, 1 year and 3 years to assess calcification scores and progression. Patients will have a pre-inclusion visit for research information and consent. If consent is given, three protocol visits (inclusion, 1 year, 3 years) including clinical exam, laboratory tests and CT evaluations will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 18 years
- •CKD defined by eGFR < 30 mL/min/1,73m²
- •signed inform consent
排除标准
- •patients on dialysis,
- •kidney transplant recipients,
- •current or recent (within 30 days) infection,
- •inflammatory diseases,
- •active cancer treatment,
- •use of immunosuppressive agents,
- •presence of coronary stents or aortic valve protheses,
- •inability to provide informed consent.
研究组 & 干预措施
CKD patients
干预措施: Thoracic CT (Other)
CKD patients
干预措施: Blood samples (Biological)
结局指标
主要结局
variation from baseline of CXCR2 expression
时间窗: at 3 years
CXCR2 expression will be quantified by flow cytometry (percentage of CXCR2-positive cells) from blood sample.
Correlation between CXCR2 expression and calcium score
时间窗: at 3 years
The coronary calcification score will be determined by Agatston method. CXCR2 expression will be quantified by flow cytometry (percentage of CXCR2-positive cells) from blood sample.
次要结局
- Correlation between leukocyte phenotype and serum indoxyl sulfate concentration(at 3 years)
- CXCR2 expression and the 1-year progression of the calcium score(at 1 year)
- Correlation between CXCR1 or CXCR2 expression and calcium score trajectory(1 year)
- Correlation between CXCR2 expression and the calcium score progression in other vascular territories(at 3 years)
- Correlation between CXCR1 expression and the calcium score progression in other vascular territories(at 3 years)
- Correlation between a CXCR1- or CXCR2-positive leukocyte phenotype and CKD progression(at 3 years)
- Correlation between a CXCR1- or CXCR2-positive leukocyte phenotype and the occurrence of cardiovascular complications(at 3 years)
- Correlation between a CXCR1- or CXCR2-positive leukocyte phenotype and mortality(at 3 years)