Cerebrovascular AccidentNCT00001840
Evaluation of Treated and Untreated Stroke
An observational study of Cerebrovascular Accident and Infarction, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebrovascular Accident, Infarction, Ischemia
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 1999to Jul 2001
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Warren G. Magnuson Clinical Center (CC)
Bethesda, Maryland, 20892
About this study
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.
- Conditions
- Cerebrovascular Accident, Infarction, Ischemia
- Keywords
- Infarct, Ischemia, MRI, Natural History, Stroke, Treatment, Brain Stroke
- Medical subject headings
- Stroke, Infarction, Ischemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startFeb 1999
- Study completionJul 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001840
- Sponsor's protocol ID
- 990041
- Other IDs
- 99-CC-0041
- Status last verified
- Jan 2001
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
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 8427107Hossmann KA. Viability thresholds and the penumbra of focal ischemia. Ann Neurol. 1994 Oct;36(4):557-65. doi: 10.1002/ana.410360404.
PubMed 7944288Bryan 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Treated and Untreated Stroke
- ClinicalTrials.gov ID
- NCT00001840
- Acronym / sponsor ID
- 990041
- Conditions
- Cerebrovascular Accident, Infarction, Ischemia
- Keywords
- Infarct, Ischemia, MRI, Natural History, Stroke, Treatment, Brain Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- Feb 1999
- Study completion
- Jul 2001
- First posted
- 10 Dec 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 8427107Wolpert 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.
- Background: PubMed 7944288Hossmann KA. Viability thresholds and the penumbra of focal ischemia. Ann Neurol. 1994 Oct;36(4):557-65. doi: 10.1002/ana.410360404.
- Background: PubMed 1688347Bryan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular Accident and Infarction, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001840, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.