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Evaluation of Treated and Untreated Stroke

This study has been completed.
Study NCT00001840.   Last updated on March 3, 2008.   Information provided by National Institutes of Health Clinical Center (CC)

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Descriptive Information Fields
Brief Title  Evaluation of Treated and Untreated Stroke
Official Title  Evaluation of Treated and Untreated Stroke
Brief Summary

This project will investigate the evolution of treated and untreated stroke in patients recruited from the collaborative brain stroke program between NINDS, CC, and Suburban Hospital. The study will use anatomical and functional imaging techniques with emphasis on the acute and subacute stage (less than one month) of the disease.

As the availability of new therapeutic options for the management of acute brain stroke increases, the need to define the evolution of the disease becomes paramount, particularly as therapeutic windows, defined by known and perhaps yet undiscovered parameters, may exist. Defining these parameters will be based on state-of-the-art imaging technology with the potential of clarifying the division between ischemia (reversible damage) and infarction (irreversible). Measures of lesion size and distribution along with vascular morphology, diffusion, perfusion, flow-related, and metabolic measures will be obtained over time. We foresee these measurements will significantly develop our understanding of cerebral ischemia and introduce diagnostic and quantitative tools to guide therapy and measure its efficacy.

Detailed Description

This project will investigate the evolution of treated and untreated stroke in patients recruited from the collaborative brain stroke program between NINDS, CC, and Suburban Hospital. The study will use anatomical and functional imaging techniques with emphasis on the acute and subacute stage (less than one month) of the disease.

As the availability of new therapeutic options for the management of acute brain stroke increases, the need to define the evolution of the disease becomes paramount, particularly as therapeutic windows, defined by known and perhaps yet undiscovered parameters, may exist. Defining these parameters will be based on state-of-the-art imaging technology with the potential of clarifying the division between ischemia (reversible damage) and infarction (irreversible). Measures of lesion size and distribution along with vascular morphology, diffusion, perfusion, flow-related, and metabolic measures will be obtained over time. We foresee these measurements will significantly improve our understanding of cerebral ischemia and introduce diagnostic and quantitative tools to guide therapy and measure its efficacy.

Study Phase
Study Type  Observational
Study Design 
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Cerebrovascular Accident
Infarction
Ischemia
Intervention 
MEDLINE PMIDs 8427107,   7944288,   1688347
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  100
Start Date  February 1999
Completion Date July 2001
Eligibility Criteria 

Any subject suspected of having a stroke based on the NIH Stroke Scale and age 21 years or over.

Subjects will be enrolled into this protocol only if they are determined intellectually capable of providing their own informed consent.

No subjects will be included if they have a condition which would preclude their entry into the scanner (e.g., paralyzed hemidiaphragm, morbid obesity, claustrophobia, etc.) or present unnecessary risks (e.g., surgery of uncertain type, symptoms of pheochromocytoma or insulinoma, etc.).

No women who are pregnant or lactating.

No subjects with hemoglobinopathies and asthma.

No subjects with renal or hepatic disease.

No subjects who have a contraindication to MR scanning such as surgery that involves metal clips or wires which might be expected to concentrate radiofrequency fields or cause tissue damage from twisting in a magnetic field (e.g., aneurysm clip, implanted neural stimulator, implanted cardiac pacemaker or autodefibrillator, cochlear implant, ocular foreign body and mechanical pump).

Gender Both
Ages
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00001840
Organization ID 990041
Secondary IDs †† 99-CC-0041
Study Sponsor  National Institutes of Health Clinical Center (CC)
Collaborators ††
Investigators 
Information Provided By National Institutes of Health Clinical Center (CC)
Verification Date January 2001
First Received Date  November 3, 1999
Last Updated Date March 3, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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