Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
4000 participants
OBSERVATIONAL
2001-01-26
Brief Summary
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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:
* Blood and urine tests not more than 2 tablespoons of blood will be drawn for various tests.
* Electrocardiogram (EKG) (heart tracing)-electrodes placed on the chest wall detect the heartbeat and heart rhythm.
* Computed tomography (CT) scan of the head-specialized X-rays are used to obtain images of the brain.
* Magnetic resonance imaging (MRI) of the brain-a strong magnetic field and radio waves are used to produce images that provide information about the brain tissue and blood vessels.
* Transcranial Doppler (TCD)-sound waves are used to image the arteries of the brain and neck.
* Echocardiogram-sound waves are used to image the heart and evaluate heart function.
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
Detailed Description
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This is a natural history/disease pathogenesis protocol for evaluation of patients with or at risk of 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 manifestation and the relationship among clinical, hematologic, and radiologic variables, as well as identifying potential subjects for future studies on stroke and other cerebrovascular diseases.
Objectives:
* To establish a registry of subjects with cerebrovascular disease including clinical, laboratory, and radiological variables associated with hemorrhagic and ischemic stroke, TIA, and other disturbances of cerebrovascular circulation.
* To characterize the natural history of acute stroke, TIA, and other disturbances of cerebrovascular circulation on these variables.
* To evaluate the relationship among these variables by exploratory analyses and to generate hypotheses for future testing.
* To identify potential subjects for research studies on stroke and other cerebrovascular diseases.
Endpoints:
A primary purpose of this observational protocol is to discover and study new imaging biomarkers that are i) relevant to the acute presentation and severity, ii) predictive of clinical outcome, and iii) are useful for stratifying the biological response as reflected in blood-biomarker and gene expression studies. As such, the primary outcome is the results from the imaging studies.
Primary Outcome Measures
Prevalence and type of abnormalities seen on neuroimaging as a function of time from acute insult such as:
* Imaging positive for acute ischemic cerebral vascular syndrome ( AICS positive )\[1\]
* 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 \[2\]
* The evolution of these markers with time and treatment
Secondary Outcome Measures
* Stroke severity as measured by NIHSS as a function of time since index event.
* Clinical outcome measured using modified Rankin Scale and Barthel Index
* Gene expression profiles and biomarker levels obtained from blood samples.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients
Patients with acute stroke symptoms
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
1. Aged \>=18
2. Presented to participating study site (ED, ICU, or inpatient unit) with or at risk of acute stroke, TIA, or other disturbances of cerebrovascular circulation
Exclusion Criteria
1. Subjects with contraindication to MRI scanning will be excluded from any testing which involves the use of MRI. The contraindications include subjects with the following devices or conditions:
* Central nervous system aneurysm clips
* Implanted neural stimulator
* Implanted cardiac pacemaker or defibrillator
* Cochlear implant
* Ocular foreign body (e.g. metal shavings)
* Insulin pump
* Metal shrapnel or bullet
* Any implanted device that is incompatible with MRI
Subjects with a condition precluding entry in the scanner (e.g. morbid obesity, Claustrophobia, etc.) will not be included in the MRI portion of this study.
2. Pregnancy
18 Years
120 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Responsible Party
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Principal Investigators
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Lawrence L Latour, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
National Institute of Neurological Disorders and Stroke (NINDS)
Locations
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Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
Suburban Hospital - Johns Hopkins Medicine
Bethesda, Maryland, United States
National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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Lawrence Latour, Ph.D.
Role: primary
Lawrence Latour, Ph.D.
Role: primary
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
Role: primary
References
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Lomahan CA, Luby M, Kalarakis G, Hsia AW, Lynch JK, Nathani KP, Somani S, Thomas LC, Arnberg-Sandor F, Latour LL. Hyperemia detection on arterial spin labeling is associated with final infarct volume in stroke post-endovascular therapy. J Stroke Cerebrovasc Dis. 2025 Aug;34(8):108358. doi: 10.1016/j.jstrokecerebrovasdis.2025.108358. Epub 2025 May 26.
Cho YE, Lee H, Bae HR, Kim H, Yun S, Vorn R, Cashion A, Rucker MJ, Afzal M, Latour L, Gill J. Circulating immune cell landscape in patients who had mild ischaemic stroke. Stroke Vasc Neurol. 2022 Aug;7(4):319-327. doi: 10.1136/svn-2021-001224. Epub 2022 Mar 9.
Luby M, Hsia AW, Nadareishvili Z, Cullison K, Pednekar N, Adil MM, Latour LL. Frequency of Blood-Brain Barrier Disruption Post-Endovascular Therapy and Multiple Thrombectomy Passes in Acute Ischemic Stroke Patients. Stroke. 2019 Aug;50(8):2241-2244. doi: 10.1161/STROKEAHA.119.025914. Epub 2019 Jun 26.
Hsia AW, Luby M, Cullison K, Burton S, Armonda R, Liu AH, Leigh R, Nadareishvili Z, Benson RT, Lynch JK, Latour LL. Rapid Apparent Diffusion Coefficient Evolution After Early Revascularization. Stroke. 2019 Aug;50(8):2086-2092. doi: 10.1161/STROKEAHA.119.025784. Epub 2019 Jun 26.
Related Links
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NIH Clinical Center Detailed Web Page
Other Identifiers
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01-N-0007
Identifier Type: -
Identifier Source: secondary_id
010007
Identifier Type: -
Identifier Source: org_study_id