Tracking Endothelial Cells in Arterial Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Standard uptake value
研究概览
简要总结
We plan to track the migratory behaviour of culture-expanded enothelial outgrowth cells in the context of vascular injury sustained during elective coronary angiography.
We will use Flouro-deoxyglucose-labelling and PET-CT to track the endothelial cells.
详细描述
The radial artery is commonly injured following trans-radial cardiac catheterisation and this injury can be demonstrated as a reduction in endothelial function as measured by flow-mediated dilatation which recovers with time (13-15). Thus the radial artery is useful as a model of mechanical arterial injury as radial artery trauma is common and endothelial function can be followed longitudinally with a non-invasive test.
Endothelial progenitor cells localise to sites of arterial injury in animal models both in vitro and in vivo and accelerate re-endothelialisation as well as attenuating neointimal hyperplasia (16-18), This has however not been demonstrated in man.
Our research group, in collaboration with the Scottish Blood Transfusion Service (SNBTS) have developed a good manufacturing practice (GMP)-compliant process for manufacturing an endothelial progenitor cell (EPC) product (SNBTS will manufacture the final product administered to patients). We have also demonstrated in vitro that we can label these cells with the radioisotope 18 F-fluorodeoxyglucose (18F-FDG) and that activity can be detected in as few as 200 cells using a hybrid positron emission and computed tomography (PET-CT) scanner (Biograph mCT Siemens Medical Systems, Erlangen, Germany). We will therefore be able to track the fate of these cells in vivo. The major potential advantage of imaging in this way is that only 18F-FDG associated with EPCs will be delivered to the patient, removing the issue of background attenuation due to "free" circulating 18F-FDG. A similar technique has previously been employed in vivo to track homing of unselected autologous bone marrow cells to infarcted myocardium(19). Following intracoronary delivery using this technique, the authors were able to detect 1.3% - 2.6% of 18F-FDG-labelled cells in the infarcted myocardium. Demonstrating that EPCs are able to home to and integrate at sites of vascular injury in man is a critical step in understanding the role of EPCs in vascular repair
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing coronary angiography for known or suspected ischaemic heart disease
排除标准
- •Previous coronary artery bypass surgery.
- •Planned angiography via the femoral artery as a sole arterial access route
- •Anaemia <10g/L
- •Severe valvular heart disease
- •Acute myocardial infarction within previous three months
- •Cardiac failure (Killip class ≥II).
- •Insulin dependent diabetes mellitus
- •Hepatic failure (Childs-Pugh grades B or C).
- •Renal failure (estimated glomerular filtration rate <25 mL/min).
- •Intercurrent illness including patients with a systemic inflammatory disorder or underlying malignancy.
- •Women of child-bearing age not ensuring reliable methods of contraception.
- •Inability to provide informed consent.
结局指标
主要结局
Standard uptake value
时间窗: 0-4 hours
Standard-uptake values of injured sections of artery will be compared to remote uninjured artery
次要结局
未报告次要终点