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

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

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.

Study Overview

• Status: Recruiting
• Conditions: 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
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Eric JOUVENT, MD, PhD; Phone Number: 33 1 49 95 65 29; Email: eric.jouvent@aphp.fr

Study Locations

• France
  • Paris, France, 75010
    • Recruiting
    • Hôpital Lariboisière
    • Contact: Eric JOUVENT, PhD; Phone Number: +33 1 49 95 65 29; Email: eric.jouvent@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to the occurrence of cognitive decline	diagnosis of mild or major neurocognitive disorder according to DSM5	5 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Eric JOUVENT, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2018
• Primary Completion (Anticipated): August 30, 2022
• Study Completion (Anticipated): August 30, 2027

Study Registration Dates

• First Submitted: March 27, 2018
• First Submitted That Met QC Criteria: June 10, 2018
• First Posted (Actual): June 12, 2018

Study Record Updates

• Last Update Posted (Actual): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 29, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Stroke; Dementia; Disability; Cerebrovascular disorders; Small subcortical infarct; Neurocognitive and cardiovascular disorders
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Brain Infarction; Cerebral Small Vessel Diseases; Thrombotic Stroke; Ischemic Stroke; Infarction; Stroke, Lacunar
• Other Study ID Numbers: P150602

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No