The Role of CD34 + Stem Cells and Biological Markers of Angiogenesis in the Development of Coronary Allograft Vasculopathy in Patients After Heart Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- CD34+ peripheral cell count in heart transplant recipients with and without coronary allograft vasculopathy
研究概览
简要总结
Coronary allograft vasculopathy represents one of the major limiting factors of long-term survival in heart transplant recipients. While extensively researched, the underlying mechanisms of coronary allograft vasculopathy (CAV) after heart transplantation remain incompletely understood. As CD34+ cells represent one of the key determinants of coronary vascular homeostasis we investigated the potential association between CAV and CD34+ cell count in heart transplant recipients.
详细描述
In a single-center prospective pilot cohort study, we aim to enroll 55 adult heart transplant recipients. All patients will undergo coronary CT angiography and the presence of CAV will be defined in accordance with the ISHLT criteria. At the time of CT angiography, patient will undergo detailed clinical evaluation, cardiac echo and we will also collect blood samples, perform extensive biochemical analysis and measure CD34+ cell count in peripheral venous blood using Beckman-Coulter Navios EX flow cytometry with standard antibodies according to ISAGE protocol. Biomarkers of angiogenesis will be evaluated using Luminex assay kit.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •heart transplant recipient
- •age > 18 years
- •signed informed consent
排除标准
- •multiorgan transplantation
- •eGFR < 30 ml/min
- •known hypersensitivity to the contrast media
- •history of any malignancy treated with radiation or chemotherapy
- •therapy with mTOR inhibitors
- •rejection > 1R within 90 days before enrollment
- •G-CSF therapy within 30 days of enrollment
结局指标
主要结局
CD34+ peripheral cell count in heart transplant recipients with and without coronary allograft vasculopathy
时间窗: at the time of enrollment
CD34+ peripheral cell count in heart transplant recipients with and without coronary allograft vasculopathy
次要结局
- The serum levels of biomarkers of angiogenesis in heart transplant recipients with and without coronary allograft vasculopathy(at the time of enrollment)
研究者
Gregor Poglajen
MD, PhD
University Medical Centre Ljubljana