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Natural History of Stroke: Cause and Development

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 362 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor

    Eligibility criteria expanded, about 13 words

    Secondary endpoints: details revised at 3 of 3 entries; Study description expanded, about 13 words; Publications: details revised at 4 of 4 entries

    Show what changed: Eligibility criteria
    * INCLUSION CRITERIA: In order to be eligible to participate i [...] udy, an individual must meet all of the following criteria: 1. Aged \>=18 2. Presented to participating study site (ED, ICU, or inpatient [...] criteria will be excluded from participation in this study: 1. Subjects with contraindication to MRI scanning will be exclu [...] 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 bul [...] [...]
    Show what changed: Study description
    [...] s on stroke and other cerebrovascular diseases. Objectives: * To establish a registry of subjects with cerebrovascular dis [...] TIA, and other disturbances of cerebrovascular circulation. * To characterize the natural history of acute stroke, TIA, an [...] urbances of cerebrovascular circulation on these variables. * To evaluate the relationship among these variables by explor [...] ory analyses and to generate hypotheses for future testing. * To identify potential subjects for research studies on strok [...] uroimaging as a function of time from acute insult such as: * Imaging positive for acute ischemic cerebral vascu [...] [...]

  2. Minor

    39 amendments

    39 re-verifications since 2025-08-22, no change to tracked fields

    v323-v361

  3. Minor

    Site contacts updated at 2 of 3 sites

    Study Status, Conditions, Eligibility, Contacts/Locationsv322

  4. Minor

    6 amendments

    6 re-verifications since 2025-04-30, no change to tracked fields

    v316-v321

  5. Minor

    Enrollment target: 3000 to 4000

    Study Status, Study Designv315

  6. Minor

    2 amendments

    2 re-verifications since 2025-03-19, no change to tracked fields

    v313-v314

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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: * 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
Trial Details
NCT Number NCT00009243
Lead Sponsor National Institute of Neurological Disorders and Stroke (NINDS)
Conditions Brain Disease, Ischemic Attack, Transient, Cerebrovascular Accident, Cerebrovascular Disorder, Vascular Diseases
Enrollment 4,000 participants
Start Date
Updated on ClinicalTrials.gov