Constitution of a Clinico-radiological Database and a Biobank for Patients With Lacunar Infarcts

Study Overview
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Brief Summary
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The aim of this study is to determine in patients with a recent lacunar strokes (<15 days), the natural history of cognitive disturbances and disability.

Detailed Description
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This bi-centric cohort study aims at determining in patients with recent lacunar strokes (<15 days), the main clinical, radiological, or genetic predictive markers of recurrent stroke, cognitive impairment, dementia, depression gait disturbances and disability.

Official Title
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Constitution of a Clinico-radiological Database and a Biobank for Patients With Lacunar Infarcts at Lariboisière Fernand-Widal and Sainte Anne Hospitals

Conditions
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Lacunar Strokes

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years and above History of recent (less than 15 days) neurological deficit related to a small subcortical infarct (evidenced by medical history or physical examination) Diagnosis of recent small subcortical infarct on MRI (hyperintensity on diffusion-weighted imaging showing an infarction in the territory of one perforating artery) presumably responsible for the corresponding neurological deficit Lesion diameter mess than 20 mm Ability to comply with scheduled follow-up and annual neurological evaluation Affiliation to the national French health insurance (sécurité sociale) Signature of informed consent Exclusion Criteria: Prior diagnosis of dementia according to DSM IV criteria Prior severe disability with Rankin scale ≥ 4 Serious concomitant systemic disorder that can compromise the follow-up study; Leukoencephalopathy of non-vascular origin; Severe psychiatric disorder; Inability to obtain an informed signed consent from the patient or his/her family; Medical contraindication or refusal to undergo cerebral magnetic resonance scanning (MRI).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to the occurrence of cognitive decline | diagnosis of mild or major neurocognitive disorder according to DSM5 | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent stroke | Time to the occurrence of one of the following event | 5 years | 
| Dementia | diagnosis of major neurocognitive disorder (dementia) according to DSMV criteria | 5 years | 
| Transient ischaemic attacks |  Transient ischemic attack  is a well recognized outcome in clinical trials in neurovascular disorders. We chose the most commonly definition of TIA according to international guidelinesorigin, without recent ischemic lesion on diffusion weighted imaging | 5 years | 
| Cardiovascular events | myocardial infarction or cardiac failure | 5 years | 
| Attacks of migraine with aura | according to international classification of headache disorders 2nd edition (ICHD-2) | 5 years | 
| Memory complaints | any spontaneous complain of memory deficit, irrespective of the neuropsychological battery results | 5 years | 
| Depression or other mood alterations |  HADS refers to Hamilton Anxiety and Depression Scale, as stated initially in the title. The scale comprises 14 questions with structured answers ranging from 0 to 3, leading to 2 scores (1 for anxiety, 1 for depression, ranging each from 0 to 21). In each case, larger values are considered to represent worse outcomes. Scores larger or equal to 11 correspond to thresholds to define anxiety and depression  | 5 years | 
| Behavioural disorders | according to DSMV classification | 5 years | 
| Balance disturbances | according to the SPPB battery | 5 years | 
| Falls | according to patient's relatives recording | 5 years | 
| Urinary complaints | any spontaneous complain from the patients and/or his relative | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Small subcortical infarct, Cerebrovascular disorders, Neurocognitive and cardiovascular disorders, Disability, Dementia, Stroke