Natural History of Stroke: Cause and Development
Natural History of Stroke: Cause and Development
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
OBJECTIVE: This is a natural history/disease pathogenesis protocol for evaluation of patients
 with or at risk for acute stroke, transient ischemic attack (TIA), or other disturbances of
 cerebrovascular circulation. The purpose of this protocol is to generate natural history data
 to serve as the basis for future hypothesis-driven protocols as well as to contribute to the
 clinical and physiological understanding of cerebrovascular disease through the description
 of disease manifestations and the relationship among clinical, hematologic, and radiologic
 variables, as well as identifying potential subjects for future studies on stroke and other
 cerebrovascular diseases.

 STUDY POPULATIONS: Patients will be recruited from the collaborative stroke program between
 NINDS and affiliated hospitals and will be followed for the duration of their
 hospitalization. Select subjects will then be seen for follow for up to one year.

 DESIGN: Clinical issues to be addressed will include disease manifestations, natural history,
 acute disease management, and psychological/behavioral impact of the disease. Because of the
 nature of acute cerebrovascular disease, it is important to note that the research performed
 under this protocol will not interfere with emergency clinical evaluation or treatment of
 subjects, as specified in the clinical care pathway in place for the standard care of stroke
 patients at participating hospitals. Due to the emergency nature of clinical evaluation and
 therapy for stroke patients, waiver of written informed consent in certain circumstances for
 minimal risk procedures during acute period (e.g., collecting extra tubes of blood during
 initial phlebotomy for emergency room blood tests) will be required when it is impossible to
 obtain consent prior to critical emergency treatment procedures that may change the values of
 the variables. Patients will not be treated with experimental therapies as part of this
 protocol. Data collected under this protocol may be shared with other NIH researchers and
 databases and the National Institutes of Neurological Disorders and Stroke (NINDS) Repository
 if the subject approves this option in the informed consent.

 OUTCOME MEASURES: In addition to clinical, imaging and laboratory data that are part of
 routine clinical care of the patient, a variety of outcomes will be collected, e.g., infarct
 volume, clinical outcomes on NIH Stroke Scale, modified Rankin Score, Barthel Index, blood
 marker of inflammation, coagulation and gene expression. Statistical analysis plans will be
 developed as specific questions and hypotheses are generated.
-  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:

 1. Central nervous system aneurysm clips;

 2. Implanted neural stimulator;

 3. Implanted cardiac pacemaker or defibrillator;

 4. Cochlear implant;

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

 6. Insulin pump;

 7. Metal shrapnel or bullet;

 8. 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.