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

NCT ID: NCT03552926

Last Updated: 2022-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-06

Study Completion Date

2027-08-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Lacunar Strokes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Eric JOUVENT, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hôpital Lariboisière

Paris, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Eric JOUVENT, MD, PhD

Role: CONTACT

33 1 49 95 65 29

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Eric JOUVENT, PhD

Role: primary

+33 1 49 95 65 29

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39569496 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P150602

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.