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NCT03366129 · ClinicalTrials.gov registry record
Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
A clinical trial, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- 81
- Enrollment target
NCT03366129: Completed study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
NCT03366129 is a clinical trial that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 81 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03366129 has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- 81 participants
- Enrollment target
Study 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 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.
Primary Outcome
Using a previously described and independently validated method, BBB permeability will be assessed at each research time point as will WMH burden. The presence of BBB will be compared with progression of WMH into normal appearing white matter (NAWM).
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2018-09-06 |
| Est. Completion | 2023-12-18 |
What the finished NCT03366129 record still lists
NCT03366129 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 81 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT03366129 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03366129 about?
NCT03366129 is a clinical study titled "Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke". 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. Rese...
What is the current status of trial NCT03366129?
This trial is currently completed. The enrollment target is 81 participants. The study started on 2018-09-06. Estimated completion is 2023-12-18.
Who is sponsoring clinical trial NCT03366129?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
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