Left Atrial Appendage Arrhythmogenic and Thrombogenic Substrate
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- stroke
研究概览
简要总结
The purpose of the project is to elucidate whether it is possible to identify which patients are at risk of forming blood clots that can cause stroke based on analysis of the electrocardiogram.
In connection with the operation, the small pouch known as the auricle of the heart is closed, which can be completely removed after closing. This procedure is common in patients with atrial fibrillation to protect the brain from stroke. In the project, all patients will have this auricle closed if they agree to participate in the project.
After closure, the auricle is usually discarded. We will analyze the blood and the auricle tissue taken (if available) in connection with the operation itself, together with the analysis of the electrocardiogram recorded before the planned heart operation.
详细描述
Patients scheduled for elective heart surgery are invited to participate. After informed consent is signed, an ECG and blood samples are gathered the day before surgery or the same day of the surgery is planned.
During surgery, the patients undergo closure of the left atrial appendage (LAA). The choice of the device is at the discretion of the surgeon. If possible, the entire LAA is removed and processed for further analysis. The right atrial appendage is likewise removed and follows the same procedure as the LAA.
The analyses include measurement of up-/down-regulated thrombosis factors and inflammatory markers.
The right and left atrial appendage tissue collected are immediately processed for micro-patch-clamp studies, and the remaining tissue is divided into a part that is frozen for later analyses and a part that is fixed and embedded in paraffin for further histological analyses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •signed informed consent AND
- •planned any open-heart surgery:
- •valve repair or replacement
- •aorta surgery
- •any combination of the above
排除标准
- •current endocarditis
- •follow-up not possible
结局指标
主要结局
stroke
时间窗: six years
number of patients with clinical stroke
次要结局
- perioperative atrial fibrillation(30 days)
- silent brain infarctions(six years)
- occurrence of atrial fibrillation during follow-up(ten years)
研究者
Helena DOMINGUEZ
MD, PhD, Associate Professor
University Hospital Bispebjerg and Frederiksberg