Lacunar Strokes Clinical Trial
— DHU-LACOfficial title:
Constitution of a Clinico-radiological Database and a Biobank for Patients With Lacunar Infarcts at Lariboisière Fernand-Widal and Sainte Anne Hospitals
| NCT number | NCT03552926 |
| Other study ID # | P150602 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 6, 2018 |
| Est. completion date | August 30, 2027 |
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.
| Status | Recruiting |
| Enrollment | 500 |
| Est. completion date | August 30, 2027 |
| Est. primary completion date | August 30, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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). |
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital Lariboisière | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to the occurrence of cognitive decline | diagnosis of mild or major neurocognitive disorder according to DSM5 | 5 years | |
| Secondary | Recurrent stroke | Time to the occurrence of one of the following event | 5 years | |
| Secondary | Dementia | diagnosis of major neurocognitive disorder (dementia) according to DSMV criteria | 5 years | |
| Secondary | Transient ischaemic attacks | " 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 | 5 years | |
| Secondary | Cardiovascular events | myocardial infarction or cardiac failure | 5 years | |
| Secondary | Attacks of migraine with aura | according to international classification of headache disorders 2nd edition (ICHD-2) | 5 years | |
| Secondary | Memory complaints | any spontaneous complain of memory deficit, irrespective of the neuropsychological battery results | 5 years | |
| Secondary | Depression or other mood alterations | " 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 " | 5 years | |
| Secondary | Behavioural disorders | according to DSMV classification | 5 years | |
| Secondary | Balance disturbances | according to the SPPB battery | 5 years | |
| Secondary | Falls | according to patient's relatives recording | 5 years | |
| Secondary | Urinary complaints | any spontaneous complain from the patients and/or his relative | 5 years |