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

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.

Full Title of Study: “Constitution of a Clinico-radiological Database and a Biobank for Patients With Lacunar Infarcts at Lariboisière Fernand-Widal and Sainte Anne Hospitals”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 30, 2022

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.

Clinical Trial Outcome Measures

Primary Measures

  • Time to the occurrence of cognitive decline
    • Time Frame: 5 years
    • diagnosis of mild or major neurocognitive disorder according to DSM5

Secondary Measures

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

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assistance Publique – Hôpitaux de Paris
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Eric JOUVENT, MD, PhD, Principal Investigator, Assistance Publique – Hôpitaux de Paris
  • Overall Contact(s)
    • Eric JOUVENT, MD, PhD, 33 1 49 95 65 29, eric.jouvent@aphp.fr

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