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Status:

COMPLETED

Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke

Lead Sponsor:

National Institute of Neurological Disorders and Stroke (NINDS)

Conditions:

Cerebrovascular Disorder

Stroke

Eligibility:

All Genders

18-99 years

Brief Summary

Background: A stroke occurs when not enough blood reaches the brain. Sometimes stroke causes changes in certain brain matter. This is called white matter hyperintensity (WMH) and can lead to mental d...

Detailed Description

Objective: To follow a cohort of stroke patients with white matter hyperintensities (WMH), using MRI, and thereby track the natural history of changes in blood-brain barrier (BBB) disruption. By estab...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA:
  • Age greater than or equal to 18
  • Have been evaluated for stroke-like symptoms or have radiographic evidence of stroke on an MRI scan.
  • Is willing to return to one of the two study sites for serial study visits.
  • Is willing to appoint a Durable Power of Attorney (DPA) for NIH research.
  • Is willing to provide written informed consent prior to participation OR a qualifying LAR will provide consent and the subject is able to provide assent.
  • EXCLUSION CRITERIA:
  • An individual who meets any of the following criteria will be excluded from this study:
  • Medical contraindications for MRI (e.g., any non-organic implant or other device such as a cardiac pacemaker or infusion pump or other metallic implants, objects, or body piercings that are not MRI-compatible or cannot be removed)
  • Psychological contraindications for MRI (e.g., claustrophobia), to be assessed at the time the medical history is collected
  • If unable to lie comfortably on their back for up to 1 hour.
  • Contraindication to gadolinium (pregnant or nursing, previous allergic reaction, renal insufficiency)
  • Known diagnosis that is thought to be the cause of their WMH (e.g. multiple sclerosis) other than chronic cerebrovascular disease, cerebral autosomal dominant arteriopathy with subcortical infarcts (CADASIL), or migraine.
  • Clinically significant medical or neurological disorders that might expose the patient to undue risk of harm, confound study outcomes or prevent the participant from completing the study; examples of such conditions include but are not limited to respiratory compromise, cardiovascular instability or cerebral edema.
  • History of an ongoing seizure disorder, structural brain abnormality or nonvascular brain injury.
  • Unlikely to be released from the hospital following the qualifying event or has severe disability preventing ambulation or verbal communication.
  • Known malignant disease or other chronic illness with poor 5-year prognosis other than dementia.
  • Attaining a six-item screener score less than 4, during screening.

Exclusion

    Key Trial Info

    Start Date :

    September 6 2018

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    December 18 2023

    Estimated Enrollment :

    81 Patients enrolled

    Trial Details

    Trial ID

    NCT03366129

    Start Date

    September 6 2018

    End Date

    December 18 2023

    Last Update

    December 8 2025

    Active Locations (3)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (3 locations)

    1

    MedStar Washington Hospital Center

    Washington D.C., District of Columbia, United States, 20010

    2

    Suburban Hospital - Johns Hopkins

    Bethesda, Maryland, United States, 20814

    3

    National Institutes of Health Clinical Center

    Bethesda, Maryland, United States, 20892