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Lacunar StrokesDHU-LACNCT03552926

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

An observational study of Lacunar Strokes, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lacunar Strokes
How many people
500 participants
Where
1 siteFrance
Study dates
6 Jun 2018to 30 Aug 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Eric JOUVENT, MD, PhD contact

33 1 49 95 65 29

eric.jouvent@aphp.fr

France1 site, 1 recruiting

  • Hôpital Lariboisière

    Paris, 75010

    Eric JOUVENT, PhD, +33 1 49 95 65 29, eric.jouvent@aphp.fr

    Recruiting

Other trials in France

About this study

Official title: 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.

Read the 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.

Conditions
Lacunar Strokes
Keywords
Small subcortical infarct, Cerebrovascular disorders, Neurocognitive and cardiovascular disorders, Disability, Dementia, Stroke
Medical subject headings
Stroke, Lacunar, Cerebrovascular Disorders, Cardiovascular Diseases, Dementia, Stroke

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to the occurrence of cognitive decline

    diagnosis of mild or major neurocognitive disorder according to DSM5

    Measured: 5 years

Secondary outcomes (11)

  1. Recurrent stroke

    Time to the occurrence of one of the following event

    Measured: 5 years

  2. Dementia

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

    Measured: 5 years

  3. 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

    Measured: 5 years

  4. Cardiovascular events

    myocardial infarction or cardiac failure

    Measured: 5 years

  5. Attacks of migraine with aura

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

    Measured: 5 years

  6. Memory complaints

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

    Measured: 5 years

  7. 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 "

    Measured: 5 years

  8. Behavioural disorders

    according to DSMV classification

    Measured: 5 years

  9. Balance disturbances

    according to the SPPB battery

    Measured: 5 years

  10. Falls

    according to patient's relatives recording

    Measured: 5 years

  11. Urinary complaints

    any spontaneous complain from the patients and/or his relative

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2018
  2. Study start6 Jun 2018
  3. Primary completion30 Aug 2022 (estimated)
  4. Study completion30 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03552926
Sponsor's protocol ID
P150602
Acronym
DHU-LAC
Status last verified
Apr 2022
First submitted
27 Mar 2018
Last updated
2 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Grosset L, Dimitrovic A, Guillonnet A, Tamazyan R, Benzakoun J, Dusonchet A, Chabriat H, Oppenheim C, Zuber M, Calvet D, Jouvent E. MRI-Proven Incident Ischemia: A New Marker of Disease Progression in Small Vessel Diseases. Stroke. 2025 Jan;56(1):39-45. doi: 10.1161/STROKEAHA.124.048046. Epub 2024 Nov 21.

    PubMed 39569496

Questions about this trial

What is this clinical trial studying?

An observational study of Lacunar Strokes, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Eric JOUVENT, MD, PhD (33 1 49 95 65 29, eric.jouvent@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to the occurrence of cognitive decline (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03552926, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022; AzTrials last refreshed its copy on 26 Oct 2026.

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