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Evaluation of Treated and Untreated Stroke
This study has been completed.
Sponsored by: National Institutes of Health Clinical Center (CC)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001840
  Purpose

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.


Condition
Cerebrovascular Accident
Infarction
Ischemia

U.S. FDA Resources
Study Type: Observational
Official Title: Evaluation of Treated and Untreated Stroke

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 100
Study Start Date: February 1999
Estimated Study Completion Date: July 2001
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001840

Locations
United States, Maryland
Warren G. Magnuson Clinical Center (CC)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
Study ID Numbers: 990041, 99-CC-0041
Study First Received: November 3, 1999
Last Updated: March 3, 2008
ClinicalTrials.gov Identifier: NCT00001840  
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Infarct
Ischemia
MRI
Natural History
Stroke
Treatment
Brain Stroke

Study placed in the following topic categories:
Necrosis
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Brain Ischemia
Brain Infarction
Ischemia
Brain Diseases
Infarction
Cerebrovascular Disorders

Additional relevant MeSH terms:
Pathologic Processes
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009