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

Recruiting

• Conditions: Lacunar Strokes

• Registration Number: NCT03552926
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2018-03-27
• Study Start: 2018-06-06
• Study First Submitted QC: 2018-06-10
• Study First Posted: 2018-06-12
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-29
• Last Update Posted: 2022-05-02
• Primary Completion: 2022-08-30
• Study Completion: 2027-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Recurrent stroke	5 years	Time to the occurrence of one of the following event
Transient ischaemic attacks	5 years	" 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
Cardiovascular events	5 years	myocardial infarction or cardiac failure
Attacks of migraine with aura	5 years	according to international classification of headache disorders 2nd edition (ICHD-2)
Urinary complaints	5 years	any spontaneous complain from the patients and/or his relative
Dementia	5 years	diagnosis of major neurocognitive disorder (dementia) according to DSMV criteria
Memory complaints	5 years	any spontaneous complain of memory deficit, irrespective of the neuropsychological battery results
Depression or other mood alterations	5 years	" 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 "
Behavioural disorders	5 years	according to DSMV classification
Balance disturbances	5 years	according to the SPPB battery
Falls	5 years	according to patient's relatives recording

Trial Locations

Locations (1)

Hôpital Lariboisière; 🇫🇷 Paris, France