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

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

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.

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Diagnostic test: Montreal Cognitive Assessment

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.

• Study Type: Observational
• Enrollment (Actual): 168

Contacts and Locations

Study Locations

• Italy
  • Padova, Italy, 35100
    • Azienda Ospedaliera di Padova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Prospective Observational Case-Control

Description

Inclusion Criteria:

• Adults patients undergoing Cardiac - Surgery intervention with extracorporeal circulation

Exclusion Criteria:

• Neurological disease before surgery

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with at least one general anesthesia in anamnesis; Patients who underwent during their life at least one anesthesia in anamnesis	Diagnostic test: Montreal Cognitive Assessment; Neuro-cognitive test evaluating general mental status and performance; Other Names: MoCA
Patient without general anesthesia in anamnesis; Patients who never underwent general anesthesia during their life	Diagnostic test: Montreal Cognitive Assessment; Neuro-cognitive test evaluating general mental status and performance; Other Names: MoCA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Mild cognitive impairment (MCI)in patients enrolled for Cardiac Surgery	Patients will be interviewed by a psychologist assessing diagnosis of MCI with Montreal Cognitive Test (Better performance with higher scores)	Patients will be subjected to Montreal Cognitive Assessment (MOCA) test one day before surgery. T

Collaborators and Investigators

• Sponsor: University of Padova
• Collaborators: Eleonora Maran; Alessandro de Laurenzis

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2019
• Primary Completion (Actual): August 28, 2023
• Study Completion (Actual): September 15, 2023

Study Registration Dates

• First Submitted: November 27, 2019
• First Submitted That Met QC Criteria: November 27, 2019
• First Posted (Actual): December 2, 2019

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: ZivagoMCI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No