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
About this trial
This is an interventional diagnostic trial for Transient Ischemic Accident
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
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
NCT ID
NCT04989608
First Posted
July 22, 2021
Last Updated
August 30, 2021
Sponsor
University Hospital, Caen
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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