Understanding the natural history of stroke and its causes
Evaluation, Pathogenesis, and Treatment of Patients With or at Risk for Cerebrovascular Disease (A Natural History/Disease Pathogenesis Protocol)
This study is trying to gather detailed information from people who have had a stroke or a mini-stroke to better understand how these conditions develop and what causes them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 4000 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 3 sites (Washington D.C., District of Columbia and 2 other locations) |
| Trial ID | NCT00009243 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather comprehensive data on patients with acute stroke or transient ischemic attacks (TIA) to better understand the natural history of these conditions. It will establish a registry of patients and collect clinical, laboratory, and radiological data to characterize the progression and outcomes of cerebrovascular diseases. The study will also explore relationships among various clinical variables and identify potential subjects for future research on stroke. Data will be collected from standard medical care procedures and additional research-focused assessments.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 18 and older who present with or are at risk of acute stroke or TIA.
Not a fit: Patients with contraindications to MRI scanning will not benefit from this study due to the nature of the imaging assessments involved.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of stroke and lead to improved prevention and treatment strategies for patients.
How similar studies have performed: While this study builds on existing knowledge of stroke, it employs a novel approach to gather natural history data that may inform future research directions.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following 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: An individual who meets any of the following criteria will be excluded from participation in this study: 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
Where this trial is running
Washington D.C., District of Columbia and 2 other locations
- Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States (Recruiting)
- Suburban Hospital - Johns Hopkins Medicine — Bethesda, Maryland, United States (Recruiting)
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Lawrence L Latour, Ph.D. — National Institute of Neurological Disorders and Stroke (NINDS)
- Study coordinator: Nicole L Peterkin
- Email: nicole.peterkin@nih.gov
- Phone: (301) 435-2395
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.