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临床试验/NCT04182477
NCT04182477已完成不适用

The Impact of Age and Number of Previous Anesthesia on the Development of Mild Cognitive Decline (MCI) in Patients Enrolled for Cardiac Surgery

University of Padova1 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2019年1月7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
168
试验地点
1
主要终点
Incidence of Mild cognitive impairment (MCI)in patients enrolled for Cardiac Surgery

研究概览

简要总结

Mild Cognitive Impairment (MCI), diagnosed with Montreal Cognitive assessment test (MoCA) define a condition that is insufficient to meet the threshold for a diagnosis of dementia, and it is an increasing health problem.

It has been related to age and comorbilities, but the linkage between MCI and number of previous anesthesia is still unclear.

详细描述

Mild Cognitive Impairment (MCI) is a common neuropsychiatric term encompassing a greater-than-expected cognitive decline for patient's age and schooling and no more than mild functional impairment that is insufficient to meet the threshold for a diagnosis of dementia (DSM-V: "mild neurocognitive disorder") thus forming part of a declining cognitive trajectory.

For the diagnosis of MCI, the core clinical criteria are: concern about a change in cognition, impairment in one or more cognitive domains, preservation of independence in functional abilities and no presence of dementia.

The Montreal Cognitive Assessment (MoCA), a test that was developed specifically for detection of MCI, has a sensitivity of 80 to 100% and specificity of 50 to 76% using a cut-off point of 25 to make diagnosis, and it has been suggested that it is better than Mini Mental Status Evaluation (MMSE) in accurately differentiating individuals with MCI from those with normal cognition.

Various risk factors have been proposed for MCI, in particular the role of multiple biological, behavioural, social and environmental factors have been investigated.

Of them, increasing in age, lower educational level, sleep-disordered breathing and vascular risk factors (e.g. diabetes and hypertension) seem to be the most important.

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults patients undergoing Cardiac - Surgery intervention with extracorporeal circulation

排除标准

  • Neurological disease before surgery

结局指标

主要结局

Incidence of Mild cognitive impairment (MCI)in patients enrolled for Cardiac Surgery

时间窗: Patients will be subjected to Montreal Cognitive Assessment (MOCA) test one day before surgery. T

Patients will be interviewed by a psychologist assessing diagnosis of MCI with Montreal Cognitive Test (Better performance with higher scores)

次要结局

未报告次要终点

研究者

发起方
University of Padova
申办方类型
Other
责任方
Principal Investigator
主要研究者

Federico Linassi

MD, Principal investigator

University of Padova

研究点 (1)

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