Longitudinal investigation of central nervous system vasculitis
Longitudinal Study for Central Nervous System Vasculitis
This study is trying to learn more about primary central nervous system vasculitis by following patients over three years to see how the disease affects them and to find better ways to measure its activity and outlook.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 6 sites (Rochester, Minnesota and 5 other locations) |
| Trial ID | NCT05734404 on ClinicalTrials.gov |
What this trial studies
This observational study aims to establish a research cohort for primary central nervous system vasculitis (CNSV), a rare and potentially fatal condition that can lead to severe neurological complications. Participants will undergo study visits every three months for the first year and annually for two additional years, during which blood samples will be collected and physical exams conducted. The study seeks to enhance understanding of the disease's natural history, pathophysiology, and potential biomarkers for assessing disease activity and prognosis. By utilizing a multicenter approach, the research aims to overcome previous limitations associated with small patient numbers and lack of comprehensive investigations.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who meet the diagnostic criteria for CNSV and have an unexplained neurologic deficit.
Not a fit: Patients who do not have CNSV or those with systemic vasculitis that could explain their symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of central nervous system vasculitis, potentially enhancing patient outcomes.
How similar studies have performed: While research on CNSV has been limited, the multicenter approach in this study may provide new insights that have not been previously explored in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: i. Diagnostic criteria for CNSV 1. The presence of an acquired and otherwise unexplained neurologic deficit 2. The presence of either classic angiographic or histopathologic features of angiitis in the CNS 3. No evidence of systemic vasculitis or any condition that could cause the angiographic or pathologic features ii. ≥18 years of age Exclusion Criteria: i. Unwilling to sign informed consent.
Where this trial is running
Rochester, Minnesota and 5 other locations
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- Vanderbilt University — Nashville, Tennessee, United States (Recruiting)
- St. Joseph's Healthcare — Hamilton, Canada (Recruiting)
- University of Toronto/Sinai Health — Toronto, Canada (Recruiting)
Study contacts
- Principal investigator: Rula Hajj-Ali, MD — The Cleveland Clinic
- Study coordinator: Carol McAlear
- Email: cmcalear@upenn.edu
- Phone: 7813214567
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.