Clinical Trials Directory

Trials / Completed

CompletedNCT04182477

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
168 (actual)
Sponsor
University of Padova · Academic / Other
Sex
All
Age
18 Years – 99 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTMontreal Cognitive AssessmentNeuro-cognitive test evaluating general mental status and performance

Timeline

Start date
2019-01-07
Primary completion
2023-08-28
Completion
2023-09-15
First posted
2019-12-02
Last updated
2023-11-07

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT04182477. Inclusion in this directory is not an endorsement.