Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03552926

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

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.

Recruiting

Interested in participating?

Request Info

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Time to the occurrence of cognitive decline

    Time frame: 5 years

    diagnosis of mild or major neurocognitive disorder according to DSM5

Secondary outcomes

  1. Recurrent stroke

    Time frame: 5 years

    Time to the occurrence of one of the following event

  2. Dementia

    Time frame: 5 years

    diagnosis of major neurocognitive disorder (dementia) according to DSMV criteria

  3. 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

  4. Cardiovascular events

    Time frame: 5 years

    myocardial infarction or cardiac failure

  5. Attacks of migraine with aura

    Time frame: 5 years

    according to international classification of headache disorders 2nd edition (ICHD-2)

  6. Memory complaints

    Time frame: 5 years

    any spontaneous complain of memory deficit, irrespective of the neuropsychological battery results

  7. 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 "

  8. Behavioural disorders

    Time frame: 5 years

    according to DSMV classification

  9. Balance disturbances

    Time frame: 5 years

    according to the SPPB battery

  10. Falls

    Time frame: 5 years

    according to patient's relatives recording

  11. Urinary complaints

    Time frame: 5 years

    any spontaneous complain from the patients and/or his relative

Study contacts

Contact information is provided by the study sponsor or research team.

Eric JOUVENT, MD, PhD

CONTACT

[email protected]

33 1 49 95 65 29

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: DHU-LAC

Important dates

Study start
2018
Primary completion
2022
Study completion
2027
First posted
Jun 12, 2018
Registry last updated
May 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.