Natural History of Stroke: Cause and Development
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|ClinicalTrials.gov Identifier: NCT00009243|
Recruitment Status : Recruiting
First Posted : January 25, 2001
Last Update Posted : October 19, 2020
|First Submitted Date||January 24, 2001|
|First Posted Date||January 25, 2001|
|Last Update Posted Date||October 19, 2020|
|Actual Study Start Date||January 26, 2001|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||Prevalence and type of abnormalities seen on neuroimaging as a function of time from acute insult [ Time Frame: Post-acute, 24 hours, 5 days/discharge, 30 days, 3 months, 6 months, 12 months ]
Neuroimaging abnormalities, such as:-Imaging positive for acute ischemic cerebral vascular syndrome ( AICS positive )-Presence of a lesion on diffusion, perfusion, and mismatch between the two-Evidence of a vascular occlusion on MR angiography-Evidence of a thrombus or hemorrhage on T2* GRE imaging-Blood-brain barrier disruption as evidence by HARM-The evolution of these markers with time and treatment
|Original Primary Outcome Measures||Not Provided|
|Current Secondary Outcome Measures
|Original Secondary Outcome Measures||Not Provided|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title||Natural History of Stroke: Cause and Development|
|Official Title||Evaluation, Pathogenesis, and Treatment of Patients With or at Risk for Cerebrovascular Disease (A Natural History/Disease Pathogenesis Protocol)|
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
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.
|Study Design||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
|Study Population||Subjects are recruited from the collaborative stroke programs between NINDS and affiliated hospitals (Suburban Hospital and MedStar Washington Hospital Center) and will be followed for the duration of their hospitalization. Select subjects will then be seen for follow up for up to one year.|
Patients with acute stroke symptoms
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Ages||18 Years and older (Adult, Older Adult)|
|Accepts Healthy Volunteers||No|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||010007
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )|
|Study Sponsor||National Institute of Neurological Disorders and Stroke (NINDS)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||May 18, 2020|