Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04182477 |
Other study ID # |
ZivagoMCI |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
January 7, 2019 |
Est. completion date |
September 15, 2023 |
Study information
Verified date |
November 2023 |
Source |
University of Padova |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
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.