Ireland
--:--IST
Recruiting Observational

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

NCT03552926 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2018-06-06
Last updated
2022-05-02

Condition(s) studied

Lacunar Strokes

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • Time to the occurrence of cognitive decline — 5 years
    diagnosis of mild or major neurocognitive disorder according to DSM5

Trial sites (1)

FacilityCityRegionStatus
Hôpital Lariboisière Paris France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03552926 on ClinicalTrials.gov ↗ ← All trials in France