NCT03376893Active, not recruiting
Epidemiology of Silent and Overt Strokes in Sickle Cell Disease
The Epidemiology of Silent and Overt Strokes in Adults With Sickle Cell Disease: a Prospective Cohort Study
Source: ClinicalTrials.gov · Last updated 13 Feb 2026
Brief summary (registry, in English)
Sickle Cell Disease (SCD) is a rare disease occurring in an estimated 100,000 individuals, often poor and underserved, in the US. Silent and overt strokes contribute significantly to morbidity in adults with SCD, resulting in functional impairment, challenges with school and job performance, and premature death. Five NIH-funded randomized controlled trials have identified therapies to prevent silent and overt strokes in children with SCD, including monthly blood transfusion therapy (for preventing initial and recurrent strokes) and hydroxyurea (for preventing initial strokes). Despite the observation that at least 99% of children with SCD in high-income countries reach adulthood, and approximately 60% of adults will experience one or more strokes (\~50% with silent strokes and \~10% with overt strokes), no stroke trials have established therapeutic approaches for adults with SCD. For adults with SCD, inadequate evidence-based guidelines exist for secondary stroke prevention strategies. Applying stroke prevention strategies in children may not be effective for stroke prevention in adults with SCD, particularly given the high rate of co-morbidities. Identifying subgroups of adults with SCD and higher incidence coupled with the contribution of established stroke risk factors in the general population (smoking, diabetes, obesity, renal disease) will provide the requisite data required for the first-ever phase III clinical trials focused on secondary stroke prevention in adults.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 102 (actual)
- First submitted
- 8 Dec 2017
- Start date
- 2 Jun 2017
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Vanderbilt University Medical Center
- Diseases
- Stroke, Sickle cell disease, Thalassaemia
- NCT number
- NCT03376893
What you commit to
- Study type: Observational
- Participants enrolled: 102
- From 2 Jun 2017 to the primary completion date, 31 Dec 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants judged to be non-compliant by the hematologist based on previous experience in terms of clinic appointments and following advice
Other
- Participants with contraindications to MRI, including individuals with MRI-incompatible foreign metal objects
Who the study is looking for
- Participants with sickle cell disease on hemoglobin analysis and/or other confirmatory documentation of phenotype
- Patients ≥ 18 years of age
- Patients followed regularly (at least two visits per year) in the hematology clinics
- Patients who have demonstrated adherence with follow-up visits for ≥ 3 years
- 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.
- Willingness to comply with study protocol, routine clinic visits
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.