An observational study in Brain Disease, Ischemic Attack, Transient and Cerebrovascular Accident, sponsored by National Institute of Neurological Disorders and Stroke (NINDS). Recruiting at 3 sites in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by National Institute of Neurological Disorders and Stroke (NINDS) · Observational
The purpose of this study is to learn more about stroke and obtain information that may serve as the basis for future investigations. It will 1) establish a registry of patients with cerebrovascular disease (stroke); 2) characterize the natural history of acute stroke and transient ischemic attacks (TIA)-an interruption of blood flow to the brain that causes stroke symptoms for a short period of time); and 3) evaluate the data to generate ideas for future studies.
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:
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
Study Description:
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:
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:
Secondary Outcome Measures
449 studies on the registry are indexed under Cerebrovascular Disorders; 127 are open to participants now.
This study's planned enrollment of 4,000 is above the median of 450 across 145 observational studies indexed under Cerebrovascular Disorders.
Browse Cerebrovascular Disorders studies →National Institute of Neurological Disorders and Stroke (NINDS) is the lead sponsor of 601 studies on the registry; 56 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 8 (44%) have results posted.
Compared within Cerebrovascular Disorders, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Brain Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Subjects are recruited from the collaborative stroke programs between NINDS and affiliated hospitals (Suburban Hospital and MedStar Washington Hospital Center) and will be followed for the duration of their hospitalization. Select subjects will then be seen for follow up for up to one year.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
Subjects with 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:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with acute stroke symptoms
Prevalence and type of abnormalities seen on neuroimaging as a function of time from acute insult
Neuroimaging abnormalities, such as:-Imaging positive for acute ischemic cerebral vascular syndrome ( AICS positive )-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"-The evolution of these markers with time and treatment
Time frame: Post-acute, 24 hours, 5 days/discharge, 30 days
Stroke severity as measured by NIHSS as a function of time since index event
Time frame: Post-acute, 24 hours, 5 days/discharge, 30 days, 3 months, 6 months, 12 months
Clinical outcome measured using modified Rankin Scale and Barthel Index
Time frame: 5 days/discharge, 30 days, 3 months, 6 months, 12 months
Gene expression profiles and biomarker levels obtained from blood samples
Time frame: Post-acute, 24 hours, 5 days/discharge, 30 days, 3 months, 6 months, 12 months
Plan to share: Yes — Individual Participant Data that underlie the results reported in the publication, after deidentification.
Supporting information: Study protocol, Informed consent form
Time frame: Beginning 3 months and ending 5 years after article publication.
Access criteria: IPD will be shared with researchers who provide a methodologically sound proposal . Proposals should be sent to the corresponding author of the publication.
Started Jan 2001 (actual).
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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National Institute of Neurological Disorders and Stroke (NINDS) →