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Protocol Details

Evaluation, Pathogenesis, and Treatment of Patients with or at Risk for Cerebrovascular Disease (A Natural History/Disease Pathogenesis Protocol)

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

01-N-0007

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

Yes

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Stroke;
Natural History;
Magnetic Resonance Imaging;
MRI (Magnetic Resonance Imaging);
Acute Stroke

Recruitment Keyword(s)

Stroke;
TIA

Condition(s)

Brain Disease;
Ischemic Attack, Transient;
Cerebrovascular Accident;
Cerebrovascular Disorder;
Vascular Diseases

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Neurological Disorders and Stroke

The purpose of this study is to learn more about stroke and obtain information that may serve as the basis for future investigations. It will 1) establish a registry of patients with cerebrovascular disease (stroke); 2) characterize the natural history of acute stroke and transient ischemic attacks (TIA) an interruption of blood flow to the brain that causes stroke symptoms for a short period of time); and 3) evaluate the data to generate ideas for future studies.

Patients 18 years of age or older with suspected acute stroke or TIA may be eligible for this study. Subjects will be recruited from patients who present with stroke at the emergency department of Suburban Hospital in Bethesda, Maryland.

The study will gather data collected from diagnostic and laboratory tests the patient undergoes as part of standard medical care, including findings of medical and neurological examinations and other tests. In addition, studies will be done for research purposes only to gather data about stroke and TIA. These may include the following:

- Blood and urine tests not more than 2 tablespoons of blood will be drawn for various tests.

- Electrocardiogram (EKG) (heart tracing) electrodes placed on the chest wall detect the heartbeat and heart rhythm.

- Computed tomography (CT) scan of the head specialized X-rays are used to obtain images of the brain.

- Magnetic resonance imaging (MRI) of the brain a strong magnetic field and radio waves are used to produce images that provide information about the brain tissue and blood vessels.

- Transcranial Doppler (TCD) sound waves are used to image the arteries of the brain and neck.

- Echocardiogram sound waves are used to image the heart and evaluate heart function.

Patients may be asked to return to Suburban Hospital for follow-up testing in 1, 3, and/or 12 months, when some of these tests may be repeated to assess changes over time

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Eligibility

INCLUSION CRITERIA:

1. Age greater than 18

EXCLUSION CRITERIA:

1. Patient is less than 18 years of age.

2. Subjects with contraindication to MRI scanning will be excluded from any testing which involves the use of MRI. These contraindications include subjects with the following devices or conditions:

a) Central nervous system aneurysm clips;

b) Implanted neural stimulator;

c) Implanted cardiac pacemaker or defibrillator;

d) Cochlear implant;

e) Ocular foreign body (e.g. metal shavings);

f) Insulin pump;

g) Metal shrapnel or bullet;

h) Any implanted device that is incompatible with MRI.

Subjects with a condition precluding entry into the scanner (e.g. morbid obesity, claustrophobia, etc.) will not be included in the MRI portion of this study. Pregnant women will be excluded from testing which involves the use of MRI.

3. Subjects will be excluded from 7T imaging if they are at risk of aspiration or have any condition that may require precipitous removal from the scanner.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Lawrence Latour, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health
Building 10
Room B1D733
36 Convent Drive
Bethesda, Maryland 20892
(301) 496-0463
latourl@ninds.nih.gov

Mariam Afzal
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health
Building 10
Room B1D733
10 Center Drive
Bethesda, Maryland 20892
(301) 435-2269
mariam.afzal@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:

NCT00009243

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