NCT03366129Completed
Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
The Natural History of Blood-Brain Barrier Disruption in Stroke Patients With White Matter Hyperintensities (A Cohort Study)
Source: ClinicalTrials.gov · Last updated 28 Sept 2026
Brief summary (registry, in English)
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 decline. But not all WMH is caused by stroke. Not all people with WMH experience mental decline. Researchers want to learn more about WMH. They want to see if it is related to disruptions in the blood-brain barrier. Objective: To better understand the how blood-brain barrier disruption is related to white matter hyperintensities. Eligibility: Adults at least 18 years old who have been admitted to a study site with stroke-like symptoms Design: Participants will be screened with an MRI scan and cognitive tests. Participants will have 11 visits over 6 years. Each visit will be 3-4 hours. At each visit, participants will: Update their medical history Have a thin plastic tube (catheter) inserted into an arm vein by needle Have an MRI. The scanner is a metal cylinder in a strong magnetic field. Participants will lie on a table that slides in and out of the cylinder. Participants will be in the scanner about 60 minutes, lying still for up to 20 minutes at a time. They will get earmuffs for loud sounds. Have a dye injected through the catheter during the MRI Have tests of movement, language, and cognition Some participants will have an extra visit for an MRI in a stronger scanner (7T MRI). Participation for some participants will be authorized by their legal representative.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 81 (actual)
- First submitted
- 7 Dec 2017
- Start date
- 6 Sept 2018
- Primary completion date
- 18 Dec 2023
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Diseases
- Stroke
- NCT number
- NCT03366129
What you commit to
- Study type: Observational
- Participants enrolled: 81
- From 6 Sept 2018 to the primary completion date, 18 Dec 2023
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindication to gadolinium (pregnant or nursing, previous allergic reaction, renal insufficiency)
Other illness
- 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)
- 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.
- Known malignant disease or other chronic illness with poor 5-year prognosis other than dementia.
Other
- An individual who meets any of the following criteria will be excluded from this study:
- 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.
- Unlikely to be released from the hospital following the qualifying event or has severe disability preventing ambulation or verbal communication.
- Attaining a six-item screener score less than 4, during screening.
Criteria the registry did not label
- 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.
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institutes of Health Clinical Center Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
| Suburban Hospital - Johns Hopkins Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
| MedStar Washington Hospital Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.