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

Constitution of a Clinico-radiological Database and a Biobank for Patients With Lacunar Infarcts at Lariboisière Fernand-Widal and Sainte Anne Hospitals

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03552926
Acronym
DHU-LAC
Enrollment
500
Registered
2018-06-12
Start date
2018-06-06
Completion date
2027-08-30
Last updated
2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lacunar Strokes

Keywords

Small subcortical infarct, Cerebrovascular disorders, Neurocognitive and cardiovascular disorders, Disability, Dementia, Stroke

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.

Interventions

None listed

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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).

Design outcomes

Primary

MeasureTime frameDescription
Time to the occurrence of cognitive decline5 yearsdiagnosis of mild or major neurocognitive disorder according to DSM5

Secondary

MeasureTime frameDescription
Recurrent stroke5 yearsTime to the occurrence of one of the following event
Transient ischaemic attacks5 yearsTransient 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
Cardiovascular events5 yearsmyocardial infarction or cardiac failure
Attacks of migraine with aura5 yearsaccording to international classification of headache disorders 2nd edition (ICHD-2)
Memory complaints5 yearsany spontaneous complain of memory deficit, irrespective of the neuropsychological battery results
Dementia5 yearsdiagnosis of major neurocognitive disorder (dementia) according to DSMV criteria
Behavioural disorders5 yearsaccording to DSMV classification
Balance disturbances5 yearsaccording to the SPPB battery
Falls5 yearsaccording to patient's relatives recording
Urinary complaints5 yearsany spontaneous complain from the patients and/or his relative
Depression or other mood alterations5 yearsHADS 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

Countries

France

Contacts

Primary ContactEric JOUVENT, MD, PhD
eric.jouvent@aphp.fr33 1 49 95 65 29

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026