NCT03552926 · RECRUITING
Constitution of a Clinico-radiological Database and a Biobank for Patients With Lacunar Infarcts
This is an observational study — no drug or device is being tested. Researchers in France are building a database and tissue bank from patients who have had a recent lacunar stroke (a small, deep brain stroke) within the past 15 days. They want to track how thinking and daily function change over time. There is no assigned treatment. The phase is unspecified because this is a data-collection effort, not a clinical intervention trial.
You may qualify if
- 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
You're excluded if
- 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).
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2022-05-02