跳至主要内容
临床试验/NCT01816308
NCT01816308Unknown不适用

Mild Cognitive Impairment (MCI) in Patients With Atrial Fibrillation (AF), Trajectories of the Progression of MCI and Factors Associated With the Progression

Texas Cardiac Arrhythmia Research Foundation1 个研究点 分布在 1 个国家目标入组 888 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
888
试验地点
1
主要终点
improvement or no-worsening in MoCA score assessed at baseline and 2 year follow-up

研究概览

简要总结

This study aims to compare the incidence of new-onset cognitive impairments and change in existing impairment status between AF patients undergoing either catheter ablation or remaining on anti-arrhythmic drugs (AAD) as assessed by Montreal Cognitive Assessment (MoCA).

详细描述

Background: AF is mostly a disease of elderly. Up to 10% of people aged 80 years or older suffer from this arrhythmia and the rate is projected to triple in the next 20 years (1). Evidence is emerging that AF may increase the risk of all forms of dementia (2). Cerebral hypoperfusion and the risk of cerebrovascular micro- and macro-embolism are plausible explanations for the predisposition for cognitive decline in AF (1). Such insults may act alone or in concert with other neuropathological changes common in the brain of older individuals such as neuritic plaques or neurofibrillary tangles, in lowering cognitive reserves and accelerating the onset of dementia (3).

Prior studies on AF and dementia have yielded conflicting results.

An earlier study provided evidence supporting an association between AF and increased incidence of dementia in patients with stroke (4). In a prospective study conducted on participants of ONTARGET and TRANSCEND trials, it was revealed that cognitive and functional decline are important consequences of atrial fibrillation, even in the absence of overt stroke (5). Another independent study, observed similar results for risk of dementia in AF in participants with and without clinically recognized stroke during follow-up (3). Evidences from a previous research demonstrated not only a significant association of AF with all forms of dementia including Alzheimer's disease, but also higher mortality rate in patients with coexistent dementia and AF (2). On the contrary, some studies did not find any significant risk-association between AF and dementia (6-8).

These contradictory results compel the necessity for a prospective study on a large population to obtain a clear understanding of the association between AF and cognitive impairment. The potential association between the two conditions can have a very important clinical implication; if there were a causal relationship between AF and dementia then the different therapeutic strategies of AF may have differing influence on dementia risk (3). Thus, this knowledge would facilitate in personalizing treatment approaches for individuals with AF.

Anti-arrhythmic drugs are considered as the first line of therapy in AF and catheter ablation is widely-recognized as the best option in drug-refractory cases. Recent published data suggested that effective rhythm-control by catheter ablation reverses the risk of dementia in AF (9). However, it was an epidemiologic study from a health-care database where ICD codes were used to identify clinical dementia. Therefore, mischaracterization of the dementia subtypes was a major possibility in their study.

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
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: ≥ 50 years, male or female subjects
  • Clinical diagnosis of AF
  • Ability to provide written, informed consent

排除标准

  • Patients with established dementia
  • MoCA score ≤ 17 on Montreal Cognitive Assessment (MoCA)
  • Use of illicit drugs
  • Alcohol use: >12 drinks/week on average
  • Clinical evidence of delirium or altered mental status
  • Medically unstable patients (acute/unstable or poorly controlled problems that would demand focused, relatively urgent or emergent medical attention)

结局指标

主要结局

improvement or no-worsening in MoCA score assessed at baseline and 2 year follow-up

时间窗: 2 years

The primary efficacy endpoint of this study will be the objective response rate (ORR); objective response being defined as improvement or no-worsening in MoCA score assessed at baseline and 2 year follow-up.

次要结局

  • Correlation between MoCA score and physical activity, social support, anxiety and depression(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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