Constitution of a Clinico-radiological Database and a Biobank for Patients With Lacunar Infarcts
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Lacunar Strokes. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Constitution of a Clinico-radiological Database and a Biobank for Patients With Lacunar Infarcts at Lariboisière Fernand-Widal and Sainte Anne Hospitals
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.
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.
Primary outcome measures
- Time to the occurrence of cognitive decline [Time frame: 5 years]
Secondary outcome measures (11)
- Recurrent stroke [Time frame: 5 years]
- Dementia [Time frame: 5 years]
- Transient ischaemic attacks [Time frame: 5 years]
- Cardiovascular events [Time frame: 5 years]
- Attacks of migraine with aura [Time frame: 5 years]
- Memory complaints [Time frame: 5 years]
- Depression or other mood alterations [Time frame: 5 years]
- Behavioural disorders [Time frame: 5 years]
- Balance disturbances [Time frame: 5 years]
- Falls [Time frame: 5 years]
- Urinary complaints [Time frame: 5 years]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Hôpital Lariboisière — Paris
Publications
- Grosset L, Dimitrovic A, Guillonnet A, Tamazyan R, Benzakoun J, Dusonchet A, Chabriat H, Oppenheim C, Zuber M, Calvet D, Jouvent E. MRI-Proven Incident Ischemia: A New Marker of Disease Progression in Small Vessel Diseases. Stroke. 2025 Jan;56(1):39-45. doi: 10.1161/STROKEAHA.124.048046. Epub 2024 Nov 21. PMID 39569496
Identifiers
NCT: NCT03552926 · P150602