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临床试验/NCT05794464
NCT05794464招募中不适用

Secretoneurin as a Biomarker of Atrial Fibrillation rEcurrence After Catheter Ablation/Electrical Cardioversion

University Hospital Ostrava2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
2
主要终点
Atrial fibrillation recurrence based on secretoneurin levels

研究概览

简要总结

Secretoneurin (SN) is a neuropeptide from the chromogranin family that influences intracellular calcium handling. SN suppresses calcium leakage from the sarcoplasmic reticulum through the ryanodine receptor. SN is a novel biomarker that has shown the potential to predict adverse arrhythmic events.

详细描述

The aim of the study is to sample SN before and after catheter ablation (CA) for atrial fibrillation (Afib) to predict the recurrence after CA. Also, the uric acid/albumin ratio will be assessed as a marker of Afib recurrence. Since the uric acid/albumin ratio has been shown to be predictive of Afib in patients with myocardial infarction moreover incidence of atrial fibrillation is higher in patients with gout. As a side branch marker for silent brain injury, neuron-specific enolase (NSE) and protein S100B will be evaluated. NSE showed in small trials a significant increase after catheter ablation, as well as S100B. The prognostic power is not clear yet. From the systematic review, the most powerful predictors seem to be N-terminal (NT)-prohormone B-type natriuretic peptide (NT-Pro-BNP/BNP), high-sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6) and Carboxy-terminal telopeptide of collagen type I. Biomarkers are divided into 3 main types: congestion, inflammation, and renal function.

Patients will be enrolled before catheter ablation/electrical cardioversion for Afib after signing IS, and the blood sampling will be performed the day before and the day after catheter ablation. In the electric cardioversion arm, the blood sampling will be performed before electrical cardioversion and 2h after the cardioversion before discharge.

Patients will be followed for recurrency - all patients will have a 24-hour ECG Holter and External loop recorder (MDT) for two weeks after the three months of the blanking period. Clinical outpatient control will ensue in the 4th, eighth,12, and 24 months.

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

盲法说明

No masking will be used in the study.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Atrial fibrillation (Afib); (paroxysmal, persistent)
  • Patients indicated for catheter ablation and/or electrical cardioversion
  • Signed informed consent

排除标准

  • Longstanding or permanent atrial fibrillation
  • Severe mitral regurgitation
  • Heart failure with a permanently reduced ejection fraction
  • Cerebral ischaemic stroke in < 3 months
  • Severe kidney injury
  • Severe renal insufficiency
  • Hepatic insufficiency limiting biomarker sampling
  • Myocardial infarction < 3 months

结局指标

主要结局

Atrial fibrillation recurrence based on secretoneurin levels

时间窗: 24 months

Atrial fibrillation recurrence based on secretoneurin levels will be assessed

次要结局

  • Brain injury detection(24 months)

研究者

发起方
University Hospital Ostrava
申办方类型
Other
责任方
Sponsor

研究点 (2)

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