Clinical trial NCT04182477: Age and Number of Previous Anesthesia on the Development of Mild Cognitive Decline (MCI)
Official title: The Impact of Age and Number of Previous Anesthesia on the Development of Mild Cognitive Decline (MCI) in Patients Enrolled for Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mild Cognitive Impairment
Lead sponsor: University of Padova
Sponsor class: OTHER
Collaborators: name: Eleonora Maran
name: Alessandro de Laurenzis
First posted: 2019-12-02
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospective Observational Case-Control

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Adults patients undergoing Cardiac - Surgery intervention with extracorporeal circulation

Exclusion Criteria:

* Neurological disease before surgery

Primary outcomes:
measure: Incidence of Mild cognitive impairment (MCI)in patients enrolled for Cardiac Surgery
timeFrame: Patients will be subjected to Montreal Cognitive Assessment (MOCA) test one day before surgery. T
Secondary outcomes:
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
Study officials:
References: