Clinical trial NCT03552926: Constitution of a Clinico-radiological Database and a Biobank for Patients With Lacunar Infarcts
Official title: Constitution of a Clinico-radiological Database and a Biobank for Patients With Lacunar Infarcts at Lariboisière Fernand-Widal and Sainte Anne Hospitals
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lacunar Strokes
Keywords: Small subcortical infarct
Cerebrovascular disorders
Neurocognitive and cardiovascular disorders
Disability
Dementia
Stroke
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2018-06-12
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief summary: 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: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Time to the occurrence of cognitive decline
timeFrame: 5 years
Secondary outcomes:
measure: Recurrent stroke
timeFrame: 5 years
measure: Dementia
timeFrame: 5 years
measure: Transient ischaemic attacks
timeFrame: 5 years
measure: Cardiovascular events
timeFrame: 5 years
measure: Attacks of migraine with aura
timeFrame: 5 years
measure: Memory complaints
timeFrame: 5 years
measure: Depression or other mood alterations
timeFrame: 5 years
measure: Behavioural disorders
timeFrame: 5 years
measure: Balance disturbances
timeFrame: 5 years
measure: Falls
timeFrame: 5 years
measure: Urinary complaints
timeFrame: 5 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Lariboisière
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Eric JOUVENT, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: