Epidemiology of Silent and Overt Strokes in Sickle Cell Disease

Running, not enrolling

Conditions studied: Anemia, Sickle Cell, Sickle Cell Disease, Stroke, Sickle Cell Thalassemia, Sickle Cell-Beta0-Thalassemia

In brief

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.

Key facts

Study ID

NCT03376893

Run by

Vanderbilt University Medical Center

People needed

102

Starts

2017-06-02

Expected to finish

2026-12-31

Last updated by the study team

2026-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Participants judged to be non-compliant by the hematologist based on previous experience in terms of clinic appointments and following advice
• Participants with contraindications to MRI, including individuals with MRI-incompatible foreign metal objects

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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