Understanding strokes in adults with sickle cell disease
The Epidemiology of Silent and Overt Strokes in Adults With Sickle Cell Disease: a Prospective Cohort Study
This study looks at how often strokes happen in adults with sickle cell disease and whether treatment with hydroxyurea helps prevent them and affects thinking skills.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 4 sites (Birmingham, Alabama and 3 other locations) |
| Trial ID | NCT03376893 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the incidence of silent and overt strokes in adults with sickle cell disease (SCD) across three major medical centers. It will compare the rates of new strokes in adults with silent strokes treated with hydroxyurea to those without strokes, while also assessing cognitive impacts and the effectiveness of blood transfusions. The study will involve regular follow-ups and neuroimaging to gather comprehensive data on stroke occurrences and cognitive health. The findings are expected to inform future clinical trials for stroke prevention in adults with SCD.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of sickle cell disease who have been compliant with regular follow-up visits.
Not a fit: Patients who are non-compliant with clinic appointments or have contraindications to MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved stroke prevention strategies and better management of cognitive health in adults with sickle cell disease.
How similar studies have performed: While there have been successful trials in children with SCD, this study represents a novel approach as it focuses on adults, where evidence-based guidelines for stroke prevention are lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Participants with sickle cell disease on hemoglobin analysis and/or other confirmatory documentation of phenotype 2. Patients ≥ 18 years of age 3. Patients followed regularly (at least two visits per year) in the hematology clinics 4. Patients who have demonstrated adherence with follow-up visits for ≥ 3 years 5. Patients willing to be followed prospectively for a minimum of 3.5 years and agree to a standard care exit MRI/MRA of the brain, as well as MRI/MRA every 12 to 18 months or participation in VUMC AHA trial with Dr. Jordan as PI. These are adults with SCA aged 18-40 years at study entry, enrolled with any infarct status (none, SCI or overt stroke) and followed prospectively. 6. Willingness to comply with study protocol, routine clinic visits Exclusion criteria: 1. Participants judged to be non-compliant by the hematologist based on previous experience in terms of clinic appointments and following advice 2. Participants with contraindications to MRI, including individuals with MRI-incompatible foreign metal objects
Where this trial is running
Birmingham, Alabama and 3 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
- Washington University School of Medicine — Saint Louis, Missouri, United States (Recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Lori C. Jordan, PhD, MD — Vanderbilt University Medical Center
- Study coordinator: Samantha Davis, Masters
- Email: samantha.davis.1@vumc.org
- Phone: +1 (615) 875-7956
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.