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Completed

NCT Number: NCT04182477

Age and Number of Previous Anesthesia on the Development of Mild Cognitive Decline (MCI)

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliera di Padova

Padova, 35100, Italy

About this study

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.

It has been estimated that MCI is itself a risk factor both for dementia (it converts to dementia at a rate of 10% per year, for delirium and Post-Operative Cognitive Decline (POCD).

Hence, this study aims to investigate the incidence of MCI in cardiac-surgery adult patients, enlisted for Coronary Artery By-Pass Grafting (CABG) or Valve Surgery, and to investigate the role of previous general anaesthesia in anamnesis as a risk factor for MCI evenience.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults patients undergoing Cardiac - Surgery intervention with extracorporeal circulation

Exclusion criteria

  • Neurological disease before surgery

Treatment and study plan

Montreal Cognitive Assessment

Diagnostic Test

Neuro-cognitive test evaluating general mental status and performance

Other names: MoCA

Primary outcomes

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

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Collaborators

  • Alessandro de Laurenzis
  • Eleonora Maran

Registry information

Official study title

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

Acronym: MCI

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Dec 2, 2019
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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