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临床试验/NCT05201989
NCT05201989已完成不适用

Biomarkers and Epigenetic Markers Associated With Pain in Patients With Symptomatic Atrial Fibrillation Compared With Controls

Region Örebro County1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年1月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
1
主要终点
Biomarkers and epigenetic markers associated with pain

研究概览

简要总结

Atrial fibrillation (AF) is the most common sustained arrhythmia and the number of patients with AF is expected to increase substantially in the coming decades. One third of patients with AF report no AF-associated symptoms, but up to one-fourth report severe symptoms. It is unclear why patients' experience of AF-related symptoms varies so much. We have previously shown that patients with symptomatic AF exhibit lower pain tolerance than patients with asymptomatic AF, as well as impaired pain inhibitory control and facilitated summation of pain, indicating that pain sensitisation may be of importance in symptomatic AF. In patients with chronic pain conditions, several biomarkers and epigenetic markers associated with generation and /or maintenance of chronic pain have been identified. Previous research of biomarkers and epigenetic markers associated with pain is sparse in patients with AF.

The objective is to study levels of biomarkers and epigenetic markers in blood in patients with symptomatic paroxysmal AF (n=100), in relation to severity of AF symptoms, and compared to age- and sex-matched controls without AF (n=100). Blood will be obtained before and after AF ablation and levels of biomarkers, epigenetic markers and cardiac and inflammatory markers, analysed. Patients will complete an AF-specific symptom and a generic health-related quality of life questionnaire.

In the future, biomarkers and epigenetic markers associated with pain may be used as a tool for evaluation of patients with AF and have an impact on individualized management. Another possibility is a rationale for future studies of novel analgesics that neutralize biomarkers or antagonizes its receptors.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • On waiting list for AF ablation (only symptomatic subjects are offered ablation)
  • Paroxysmal AF and persistent AF (AF that is continuously sustained beyond 7 days, including episodes terminated by cardioversion after ≥7 days)
  • Written informed consent

排除标准

  • Previous pulmonary vein isolation
  • Cognitive or psychiatric condition
  • Diabetes mellitus
  • Ischemic heart disease
  • Heart failure
  • Pregnancy
  • Previous/current drug or alcohol abuse
  • Previous neurological or concomitant musculoskeletal disorders
  • Continuous analgesic medication

结局指标

主要结局

Biomarkers and epigenetic markers associated with pain

时间窗: 3 days

Blood tests will be obtained from subjects the day before, and the day after a planned AF ablation. A total of 30 ml of blood will be obtained at each occasion. The samples will be studied for the association of biomarkers and epigenetic markers to the severity of AF symptoms. Blood samples will be obtained from participants without AF (controls). Biomarkers and epigenetic markers will be compared between the control group and the group with symptomatic AF.

次要结局

  • Correlation of age, sex, AF duration, health-related quality of life to biomarkers and epigenetic markers.(1 day)

研究者

发起方
Region Örebro County
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anna Björkenheim

Principal investigator

Region Örebro County

研究点 (1)

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