Natural History of Stroke: Cause and Development

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.