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Sponsored by: |
National Institute of Neurological Disorders and Stroke (NINDS) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00009243 |
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:
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
Condition |
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Cerebrovascular Accident Transient Ischemic Attack |
Study Type: | Observational |
Official Title: | Evaluation, Pathogenesis, and Treatment of Patients With or at Risk For Cerebrovascular Disease (A Natural History/Disease Pathogenesis Protocol) |
Estimated Enrollment: | 2000 |
Study Start Date: | January 2001 |
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.
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 patients will then be seen for follow for up to 5 years.
DESIGN: Clinical issues to be addressed will include disease manifestations, natural history, acute disease management, and psychological/behavioral impact of the disease. Bcause 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 patients, 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 (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 as part of the SPOTRIAS Network if the patient 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 DNA. Statistical analysis plans will be developed as specific questions and hypotheses are generated.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
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.
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, District of Columbia | |
Washington Hospital Center | Recruiting |
Washington, District of Columbia, United States, 20010 | |
United States, Maryland | |
Suburban Hospital | Recruiting |
Bethesda, Maryland, United States, 20814 | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Study ID Numbers: | 010007, 01-N-0007 |
Study First Received: | January 24, 2001 |
Last Updated: | January 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00009243 History of Changes |
Health Authority: | United States: Federal Government |
Stroke TIA MRI Diffusion |
Perfusion Natural History Stroke TIA |
Ischemic Attack, Transient Cerebral Infarction Stroke Vascular Diseases Central Nervous System Diseases Brain Ischemia |
Brain Infarction Ischemia Brain Diseases Infarction Cerebrovascular Disorders |
Ischemic Attack, Transient Cerebral Infarction Nervous System Diseases Stroke Vascular Diseases Central Nervous System Diseases |
Brain Ischemia Cardiovascular Diseases Brain Infarction Brain Diseases Cerebrovascular Disorders |