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CompletedNCT00001840Updated Mar 4, 2008

Evaluation of Treated and Untreated Stroke

An observational study in Cerebrovascular Accident, Infarction and Ischemia, sponsored by National Institutes of Health Clinical Center (CC). Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2008-03-04.

Sponsored by National Institutes of Health Clinical Center (CC) · Observational

Study type
Observational
Enrollment
100
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cerebrovascular Accident
  • Infarction
  • Ischemia

Keywords

  • Infarct
  • Ischemia
  • MRI
  • Natural History
  • Stroke
  • Treatment
  • Brain Stroke
03

In context

Stroke

7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.

This study's enrollment of 100 is below the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

National Institutes of Health Clinical Center (CC) is the lead sponsor of 367 studies on the registry; 27 are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 18 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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).

05

Study design

Enrollment
100 participants
06

Study locations

1 site
  • Warren G. Magnuson Clinical Center (CC)
    Bethesda, Maryland 20892, United States
07

References and documents

Publications

  • Wolpert SM, Bruckmann H, Greenlee R, Wechsler L, Pessin MS, del Zoppo GJ. Neuroradiologic evaluation of patients with acute stroke treated with recombinant tissue plasminogen activator. The rt-PA Acute Stroke Study Group. AJNR Am J Neuroradiol. 1993 Jan-Feb;14(1):3-13. PubMed 8427107 ↗
  • Hossmann KA. Viability thresholds and the penumbra of focal ischemia. Ann Neurol. 1994 Oct;36(4):557-65. doi: 10.1002/ana.410360404. PubMed 7944288 ↗
  • Bryan RN, Levy LM, Whitlow WD, Killian JM, Preziosi TJ, Rosario JA. Diagnosis of acute cerebral infarction: comparison of CT and MR imaging. AJNR Am J Neuroradiol. 1991 Jul-Aug;12(4):611-20. PubMed 1688347 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00001840
Lead sponsor
National Institutes of Health Clinical Center (CC)
First posted
Dec 10, 2002
Start date
Feb 1999
Completion
Jul 2001
Last update
Mar 4, 2008
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2001. You cannot join it, but the record below documents what was studied.

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