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
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 Years
Max Age: 120 Years |
Referral Letter Required |
Yes |
Population Exclusion(s) |
Children;
Fetuses;
Pregnant Women |
Keywords |
Stroke;
Natural History;
MRI (Magnetic Resonance Imaging);
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
Eligibility
INCLUSION CRITERIA:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
1. Aged >=18
2. Presented to participating study site (ED, ICU, or inpatient unit) with or at risk of acute stroke, TIA, or other disturbances of cerebrovascular circulation
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
1. Subjects with contraindication to MRI scanning will be excluded from any testing which involves the use of MRI. The contraindications include subjects with the following devices or conditions:
-Central nervous system aneurysm clips
-Implanted neural stimulator
-Implanted cardiac pacemaker or defibrillator
-Cochlear implant
-Ocular foreign body (e.g. metal shavings)
-Insulin pump
-Metal shrapnel or bullet
-Any implanted device that is incompatible with MRI
Subjects with a condition precluding entry in the scanner (e.g. morbid obesity, Claustrophobia, etc.) will not be included in the MRI portion of this study.
2. Pregnancy
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT00009243