Mild Cognitive ImpairmentMCINCT04182477
Age and Number of Previous Anesthesia on the Development of Mild Cognitive Decline (MCI)
An observational study of Mild Cognitive Impairment, run by University of Padova at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Montreal Cognitive Assessment
- How many people
- 168 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jan 2019to 15 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Prospective Observational Case-Control
Who may be able to join
- Adults patients undergoing Cardiac - Surgery intervention with extracorporeal circulation
Who cannot join
- Neurological disease before surgery
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Montreal Cognitive Assessment
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montreal Cognitive AssessmentDiagnostic test
Also called MoCA
Neuro-cognitive test evaluating general mental status and performance
| Study group | Role | What they receive |
|---|---|---|
| Patients with at least one general anesthesia in anamnesis | Patients who underwent during their life at least one anesthesia in anamnesis Receives: Diagnostic Test: Montreal Cognitive Assessment | |
| Patient without general anesthesia in anamnesis | Patients who never underwent general anesthesia during their life Receives: Diagnostic Test: Montreal Cognitive Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Patients will be subjected to Montreal Cognitive Assessment (MOCA) test one day before surgery. T
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start7 Jan 2019
- Primary completion28 Aug 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Collaborators
- Eleonora Maran, Alessandro de Laurenzis
- Responsible party
- Principal investigator, Federico Linassi, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182477
- Sponsor's protocol ID
- ZivagoMCI
- Acronym
- MCI
- Status last verified
- Nov 2023
- First submitted
- 27 Nov 2019
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04182477
- Acronym / sponsor ID
- MCI / ZivagoMCI
- Conditions
- Mild Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Collaborators
- Eleonora Maran, Alessandro de Laurenzis
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 28 Aug 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 2 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with at least one general anesthesia in anamnesis | – | Diagnostic Test: Montreal Cognitive AssessmentPatients who underwent during their life at least one anesthesia in anamnesis |
| Patient without general anesthesia in anamnesis | – | Diagnostic Test: Montreal Cognitive AssessmentPatients who never underwent general anesthesia during their life |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prospective Observational Case-Control
Key inclusion criteria (1 listed)
- Adults patients undergoing Cardiac - Surgery intervention with extracorporeal circulation
Key exclusion criteria (1 listed)
- Neurological disease before surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Montreal Cognitive AssessmentAlso: MoCANeuro-cognitive test evaluating general mental status and performance | Diagnostic test | Patient without general anesthesia in anamnesis, Patients with at least one general anesthesia in anamnesis |
Primary outcome
Incidence of Mild cognitive impairment (MCI)in patients enrolled for Cardiac Surgery
Time frame: Patients will be subjected to Montreal Cognitive Assessment (MOCA) test one day before surgery. T
Patients will be interviewed by a psychologist assessing diagnosis of MCI with Montreal Cognitive Test (Better performance with higher scores)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment, run by University of Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Mild cognitive impairment (MCI)in patients enrolled for Cardiac Surgery (time frame: Patients will be subjected to Montreal Cognitive Assessment (MOCA) test one day before surgery. T). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023; AzTrials last refreshed its copy on 7 Nov 2026.