Protocol Number: 01-N-0007

Title:

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

Number:

01-N-0007

Summary:

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

Sponsoring Institute:

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

Patients will be recruited for enrollment in this protocol from the Stroke Program at the participating hospital.

EXCLUSION CRITERIA:

Patients is less than 18 years of age.

Patients with contraindication to MRI scanning will be excluded from any testing which involves the use of MRI. These contraindications include patients 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.

Patients 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.

Pregnant women will be excluded from CT scans specific to this protocol.

Special Instructions:

Currently Not Provided

Keywords:

Stroke

TIA

MRI

Diffusion

Perfusion

Natural History

Recruitment Keyword(s):

Stroke

TIA

Condition(s):

Cerebrovascular Accident

Transient Ischemic Attack

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institute of Neurological Disorders and Stroke

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Incidence and occurrence of total (first-ever and recurrent) stroke

Incidence of transient ischemic attack in Rochester, Minnesota, 1985-1989

Intravenous tissue plasminogen activator for acute ischemic stroke: feasibility, safety, and efficacy in the first year of clinical practice

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National Institutes of Health Clinical Center Bethesda, Maryland 20892. Last update: 01/13/2009