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临床试验/NCT06405750
NCT06405750
招募中
不适用

Left Atrial Appendage Arrhythmogenic and Thrombogenic Substrate

University Hospital Bispebjerg and Frederiksberg1 个研究点 分布在 1 个国家目标入组 1,000 人2024年8月1日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Atrial Fibrillation
发起方
University Hospital Bispebjerg and Frederiksberg
入组人数
1000
试验地点
1
主要终点
stroke
状态
招募中
最后更新
3个月前

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.

注册库
clinicaltrials.gov
开始日期
2024年8月1日
结束日期
2035年12月31日
最后更新
3个月前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

发起方
University Hospital Bispebjerg and Frederiksberg
责任方
Principal Investigator
主要研究者

Helena DOMINGUEZ

MD, PhD, Associate Professor

University Hospital Bispebjerg and Frederiksberg

入排标准

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)

研究点 (1)

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