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Constitution of a Clinico-radiological Database and a Biobank for Patients With Lacunar Infarcts (DHU-LAC)

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ClinicalTrials.gov Identifier: NCT03552926
Recruitment Status : Not yet recruiting
First Posted : June 12, 2018
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Lacunar Strokes

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 Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Constitution of a Clinico-radiological Database and a Biobank for Patients With Lacunar Infarcts at Lariboisière Fernand-Widal and Sainte Anne Hospitals
Estimated Study Start Date : June 30, 2018
Estimated Primary Completion Date : August 30, 2022
Estimated Study Completion Date : August 30, 2027



Primary Outcome Measures :
  1. Time to the occurrence of cognitive decline [ Time Frame: 5 years ]
    diagnosis of mild or major neurocognitive disorder according to DSM5


Secondary Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
serum and plasma samples


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with recent small subcortical infarct (less than 15 days) evaluated as outpatient or inpatient in the Neurology Departments at the Hospital Lariboisière Fernand-Widal or at the Centre Hospitalier Sainte-Anne in Paris
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552926


Contacts
Contact: Eric JOUVENT, MD, PhD 33 1 49 95 65 29 eric.jouvent@aphp.fr

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Study Chair: Paris FRANCE Hôpital Lariboisière Fernand-Widal PARIS 75010 FRANCE

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03552926     History of Changes
Other Study ID Numbers: P150602
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Small subcortical infarct
Cerebrovascular disorders
Neurocognitive and cardiovascular disorders
Disability
Dementia
Stroke

Additional relevant MeSH terms:
Infarction
Stroke, Lacunar
Ischemia
Pathologic Processes
Necrosis
Cerebral Small Vessel Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stroke
Vascular Diseases
Cardiovascular Diseases