Reappraisal of Atrial Fibrillation: Interaction Between HyperCoagulability, Electrical Remodeling, and Vascular Destabilisation in the Progression of AF- The Tissue Bank Project
试验速览
- 阶段
- 不适用
- 入组人数
- 380
- 试验地点
- 1
- 主要终点
- Biochemical factors in atrial biopsies and blood samples
研究概览
简要总结
In the proposed study the investigators aim to clarify the relative contribution of these different mechanisms to the progression of atrial fibrillation (AF). Also the contribution of the individual genetic background will be investigated. Furthermore, the investigators aim to identify clinical parameters and biomarkers informing on the main mechanisms of AF progression in atrial tissue.
For this purpose, in all included patients atrial biopsies will be taken during cardiac surgery.
详细描述
An estimated 380 patients will be included
Four patient categories will be included enabling to study patients with different stages of AF progression;
- Patients without history of atrial fibrillation, without new onset atrial fibrillation detected by continuous rhythm monitoring after surgery (control group),
- Patients without history of atrial fibrillation, with new onset atrial fibrillation detected by continuous rhythm monitoring,
- Patients with self-terminating atrial fibrillation at inclusion, and
- Patients with non-self-terminating atrial fibrillation at inclusion. At baseline in-depth phenotyping and genotyping will be performed. Continuous rhythm monitoring will also be performed in all patients. The combination of extensive phenotyping, genotyping and atrial fibrillation burden follow-up offers the unique opportunity to study the atrial tissue alterations and atrial gene expression changes in different stages of atrial fibrillation progression and to correlate these data to the phenotype of the patients.
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
- •Age > 18 years;
- •Undergoing first elective open chest cardiac surgery or surgical ablation for atrial fibrillation;
- •Able and willing to sign informed consent for the registry;
- •Able and willing to undergo implantation of implantable loop recorder (unless the patients has a pacemaker or implantable cardioverter-defibrillator (ICD) with atrial leads)
排除标准
- •• Deemed unsuitable or not willing to undergo implantation of implantable loop recorder or attend follow-up visits.
- •Pregnancy.
- •Life expectancy of less than 2.5 years.
- •History of prior cardiac surgery or ablation for atrial fibrillation.
结局指标
主要结局
Biochemical factors in atrial biopsies and blood samples
时间窗: 2.5 year follow up
Biochemical factors in atrial biopsies and blood samples associated with atrial fibrillation and contributing to atrial fibrillation progression
Molecular factors in atrial biopsies and blood samples
时间窗: 2.5 year follow up
Molecular factors in atrial biopsies and blood samples associated with atrial fibrillation and contributing to atrial fibrillation progression
Genetic factors in atrial biopsies and blood samples
时间窗: 2.5 year follow up
Genetic factors in atrial biopsies and blood samples associated with atrial fibrillation and contributing to atrial fibrillation progression
次要结局
- AF complexity(2.5 year follow up)
- Atrial fibrillation burden(2.5 year follow up)
- Major adverse cardiovascular and cerebrovascular events(2.5 year follow up)
- First recurrent atrial fibrillation;(2.5 year follow up)
- AF progression(2.5 year follow up)
- Number of atrial fibrillation episodes(2.5 year follow up)
- Duration of atrial fibrillation episodes(2.5 year follow up)
研究者
J. G. Maessen
Prof. Dr.
Academisch Ziekenhuis Maastricht