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

Assistance Publique - Hôpitaux de Paris500 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Lacunar Strokes

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Hôpital Lariboisière

Paris, France

RECRUITING

Outcomes

Primary Outcomes

Time to the occurrence of cognitive decline

diagnosis of mild or major neurocognitive disorder according to DSM5

Time frame: 5 years

Secondary Outcomes

Recurrent stroke

Time to the occurrence of one of the following event

Time frame: 5 years

Dementia

diagnosis of major neurocognitive disorder (dementia) according to DSMV criteria

Time frame: 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

Time frame: 5 years

Cardiovascular events

myocardial infarction or cardiac failure

Time frame: 5 years

Attacks of migraine with aura

according to international classification of headache disorders 2nd edition (ICHD-2)

Time frame: 5 years

Memory complaints

any spontaneous complain of memory deficit, irrespective of the neuropsychological battery results

Time frame: 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 "

Central Contacts

Eric JOUVENT, MD, PhD

CONTACT

33 1 49 95 65 29 eric.jouvent@aphp.fr

Data from ClinicalTrials.gov

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