NCT04182477

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 2, 2019

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2023

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

4.6 years

First QC Date

November 27, 2019

Last Update Submit

November 6, 2023

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

Patient without general anesthesia in anamnesis

Patients who never underwent general anesthesia during their life

Diagnostic Test: Montreal Cognitive Assessment

Interventions

Montreal Cognitive AssessmentDIAGNOSTIC_TEST

Neuro-cognitive test evaluating general mental status and performance

Also known as: MoCA
Patient without general anesthesia in anamnesisPatients with at least one general anesthesia in anamnesis

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Prospective Observational Case-Control

You may qualify if:

  • Adults patients undergoing Cardiac - Surgery intervention with extracorporeal circulation

You may not qualify if:

  • Neurological disease before surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliera di Padova

Padua, 35100, Italy

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Principal investigator

Study Record Dates

First Submitted

November 27, 2019

First Posted

December 2, 2019

Study Start

January 7, 2019

Primary Completion

August 28, 2023

Study Completion

September 15, 2023

Last Updated

November 7, 2023

Record last verified: 2023-11

Locations

IT(1)