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Correlation Between Cognition and Neuroimaging in TIA Patients (COG-TIA)

Primary Purpose

Transient Ischemic Accident

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Neuroimaging
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Transient Ischemic Accident

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Transient ischemic accident Group

  • Patient over 60 years of age with a transient ischemic attack (focal neurological deficit of less than 24 hours without ischemic injury on diffusion MRI performed in the week following the event.)
  • Patient having signed a free and informed consent to participate in the Normandy-Stroke cohort.

Control group

  • Subject over 60 years old
  • Subject included in the Medit-AGEING research protocol
  • Subject with one or more risk factor (s) for cerebrovascular disease
  • Subject not opposing the use of their data for the Cog-Tia study

Non inclusion criteria

Transient ischemic accident Group

  • Patient with contraindications to performing a brain MRI
  • Neurological co-morbidity (history of severe head trauma, dementia, brain tumor, stroke, psychosis)
  • Refusal to participate in the Normandy-Stroke cohort
  • Persons deprived of their liberty by a judicial or administrative decision, persons undergoing psychiatric care, persons admitted to a health or social establishment for purposes other than that of research
  • Adult persons subject to a legal protection measure or unable to express their consent

Control group

- Subject refusing to the use of their data for the Cog-Tia study

Exclusion Criteria:

  • New stroke during the study participation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    patients having suffered to transient ischemic accident

    healthy volunteers

    Arm Description

    Outcomes

    Primary Outcome Measures

    correlation coefficients between variations in cognitive performance assessed from a composite neuropsychological score and structural modifications
    Calculation of correlation coefficients between variations in cognitive performance assessed from a composite neuropsychological score and structural modifications
    correlation coefficients between variations in cognitive performance assessed from a composite neuropsychological score and structural modifications
    Calculation of correlation coefficients between variations in cognitive

    Secondary Outcome Measures

    Full Information

    First Posted
    July 22, 2021
    Last Updated
    August 30, 2021
    Sponsor
    University Hospital, Caen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04989608
    Brief Title
    Correlation Between Cognition and Neuroimaging in TIA Patients
    Acronym
    COG-TIA
    Official Title
    Cognitive Profile and Correlates in Neuroimaging After a Transient Ischemic Accident
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 15, 2021 (Anticipated)
    Primary Completion Date
    May 15, 2025 (Anticipated)
    Study Completion Date
    May 15, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Caen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Context: Cognitive impairment is common after a stroke. Out of 100 patients who have suffered a stroke, 50 will develop cognitive impairment. For 16 of them, they will be responsible for an impact on autonomy (major cognitive disorder). They are conventionally attributed either to the location of the lesions or to their general volume. However, recent literature emphasizes the presence of cognitive impairment after a transient ischemic attack (TIA), when by definition the symptoms are transient and imaging without recent ischemic injury. The mechanisms of cognitive impairment in TIA are therefore poorly understood at present. There is evidence in animal models and humans for persistent brain toxicity from ischemia even in the absence of established necrosis. However, to what extent this toxicity may explain the cognitive impairment seen in TIA is not known. Indeed, the latter could just as much have the effect of vascular risk factors which significantly increase cognitive risk even in the absence of an acute event. Objective: The objective of the Cog-TIA program is therefore to identify whether the transient ischemic attack may be responsible for long-term structural changes in neuroimaging in the ischemic territory and whether these changes are correlated with changes in cognitive efficiency. Material and methods: The project is based on the Normandy-Stroke population cohort which includes patients from Caen and the surrounding area who have had a stroke or TIA. The protocol provides for neuropsychological tests evaluating the main cognitive domains at 1 year and 3 years after the initial event. The Cog-TIA project is designed as an ancillary study to the Normandy-Stroke project with the objective of including 50 patients from this cohort who presented with a transient ischemic attack. Each patient will receive a structural MRI at the same time as the neuropsychological assessments scheduled for the Normandy-Stroke study. Analyzes will be performed from T1 sequences, Proton density with centered on the hippocampus and diffusion tensors. For the T1 and proton density sequences, the analyzes will compare the volumes of the different structures longitudinally (in particular: the total hippocampal volume and of the subfields, lobar, thalamic and pallidal volumes). For the diffusion tensor analyzes, the anisotropy maps will be compared longitudinally. For each structure showing significant variation during follow-up, correlations will be made with the decline in performance on neuropsychological tests calculated using composite scores. Cognitive decline may be partly attributed to TIA if it is correlated with abnormalities in the affected hemisphere.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Transient Ischemic Accident

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    patients having suffered to transient ischemic accident
    Arm Type
    Other
    Arm Title
    healthy volunteers
    Arm Type
    Other
    Intervention Type
    Other
    Intervention Name(s)
    Neuroimaging
    Intervention Description
    realization of a neuroimaging 1 and 3 years after the transient ischemic accident
    Primary Outcome Measure Information:
    Title
    correlation coefficients between variations in cognitive performance assessed from a composite neuropsychological score and structural modifications
    Description
    Calculation of correlation coefficients between variations in cognitive performance assessed from a composite neuropsychological score and structural modifications
    Time Frame
    1 year after the transient ischemic accident
    Title
    correlation coefficients between variations in cognitive performance assessed from a composite neuropsychological score and structural modifications
    Description
    Calculation of correlation coefficients between variations in cognitive
    Time Frame
    3 years after the transient ischemic accident

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Transient ischemic accident Group Patient over 60 years of age with a transient ischemic attack (focal neurological deficit of less than 24 hours without ischemic injury on diffusion MRI performed in the week following the event.) Patient having signed a free and informed consent to participate in the Normandy-Stroke cohort. Control group Subject over 60 years old Subject included in the Medit-AGEING research protocol Subject with one or more risk factor (s) for cerebrovascular disease Subject not opposing the use of their data for the Cog-Tia study Non inclusion criteria Transient ischemic accident Group Patient with contraindications to performing a brain MRI Neurological co-morbidity (history of severe head trauma, dementia, brain tumor, stroke, psychosis) Refusal to participate in the Normandy-Stroke cohort Persons deprived of their liberty by a judicial or administrative decision, persons undergoing psychiatric care, persons admitted to a health or social establishment for purposes other than that of research Adult persons subject to a legal protection measure or unable to express their consent Control group - Subject refusing to the use of their data for the Cog-Tia study Exclusion Criteria: New stroke during the study participation
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Romain SCHNECKENBURGER, MD
    Phone
    0231065298
    Email
    schneckenburger-r@chu-caen.fr

    12. IPD Sharing Statement

    Learn more about this trial

    Correlation Between Cognition and Neuroimaging in TIA Patients

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