Constitution of a Clinico-radiological Database and a Biobank for Patients With Lacunar Infarcts (DHU-LAC)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.
Read our disclaimer for details.
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.
Condition or disease
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.
Time to the occurrence of cognitive decline [ Time Frame: 5 years ]
diagnosis of mild or major neurocognitive disorder according to DSM5
Secondary Outcome Measures :
Recurrent stroke [ Time Frame: 5 years ]
Time to the occurrence of one of the following event
Dementia [ Time Frame: 5 years ]
diagnosis of major neurocognitive disorder (dementia) according to DSMV criteria
Transient ischaemic attacks [ Time Frame: 5 years ]
" 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
Cardiovascular events [ Time Frame: 5 years ]
myocardial infarction or cardiac failure
Attacks of migraine with aura [ Time Frame: 5 years ]
according to international classification of headache disorders 2nd edition (ICHD-2)
Memory complaints [ Time Frame: 5 years ]
any spontaneous complain of memory deficit, irrespective of the neuropsychological battery results
Depression or other mood alterations [ Time Frame: 5 years ]
" 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 "
Behavioural disorders [ Time Frame: 5 years ]
according to DSMV classification
Balance disturbances [ Time Frame: 5 years ]
according to the SPPB battery
Falls [ Time Frame: 5 years ]
according to patient's relatives recording
Urinary complaints [ Time Frame: 5 years ]
any spontaneous complain from the patients and/or his relative
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with recent small subcortical infarct (less than 15 days) evaluated as outpatient or inpatient in the Neurology Departments at the Hospital Lariboisière Fernand-Widal or at the Centre Hospitalier Sainte-Anne in Paris
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
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).