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Protocol Details

The Natural History of Blood-Brain Barrier Disruption in Stroke Patients with White Matter Hyperintensities (A Cohort Study)

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

18-N-0020

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

CEREBROVASCULAR DISEASE;
Vascular Cognitive Impairment;
Stroke;
Permeability Imaging

Recruitment Keyword(s)

None

Condition(s)

Cerebrovascular Disorder;
Stroke;
Aging

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Neurological Disorders and 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. 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.

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Eligibility

INCLUSION CRITERIA:

-Age greater than or equal to 18

-Have been admitted to one of the study sites for evaluation of stroke-like symptoms ( qualifying event ) such as difficulty moving or speaking, blurred vision, dizziness or balance issues; and had an MRI scan. Symptoms must be attributable to a stroke or TIA with no other definitive cause identified at the time of screening.

-Provides written informed consent prior to study participation OR is able to provided assent and consent is provided by a qualifying LAR.

-Is willing to return to one of the two study sites to initiate serial study visits between 3-4 months whenever possible, but could be up to 6 months from the qualifying event and continue participation for at least one year.

Is willing to appoint a Durable Power of Attorney (DPA) for NIH research

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 MoCA score less than or equal to 13 during screening assessment.


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Citations:

Leigh R, Jen SS, Varma DD, Hillis AE, Barker PB. Arrival time correction for dynamic susceptibility contrast MR permeability imaging in stroke patients. PLoS One. 2012;7(12):e52656. doi: 10.1371/journal.pone.0052656. Epub 2012 Dec 20.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Richard Leigh, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)



Marwah Zagzoug, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health
Building 10
Room B1D733
10 Center Drive
Bethesda, Maryland 20892
(301) 402-6392
marwah.zagzoug@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT03366129

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