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

NCT ID: NCT04182477

Last Updated: 2023-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

168 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-07

Study Completion Date

2023-09-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Mild Cognitive Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with at least one general anesthesia in anamnesis

Patients who underwent during their life at least one anesthesia in anamnesis

Montreal Cognitive Assessment

Intervention Type DIAGNOSTIC_TEST

Neuro-cognitive test evaluating general mental status and performance

Patient without general anesthesia in anamnesis

Patients who never underwent general anesthesia during their life

Montreal Cognitive Assessment

Intervention Type DIAGNOSTIC_TEST

Neuro-cognitive test evaluating general mental status and performance

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Montreal Cognitive Assessment

Neuro-cognitive test evaluating general mental status and performance

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MoCA

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adults patients undergoing Cardiac - Surgery intervention with extracorporeal circulation

Exclusion Criteria

* Neurological disease before surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Eleonora Maran

UNKNOWN

Sponsor Role collaborator

Alessandro de Laurenzis

UNKNOWN

Sponsor Role collaborator

University of Padova

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Federico Linassi

MD, Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Azienda Ospedaliera di Padova

Padua, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ZivagoMCI

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.