Status:
RECRUITING
Epidemiology of Silent and Overt Strokes in Sickle Cell Disease
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
Washington University School of Medicine
University of Alabama at Birmingham
Conditions:
Anemia, Sickle Cell
Sickle Cell Disease
Eligibility:
All Genders
18+ years
Brief Summary
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 adul...
Detailed Description
In three adult SCD centers, we will conduct a prospective cohort study to test the primary hypothesis that the incidence of infarct recurrence (stroke or silent stroke) or new strokes in adults with s...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
- Exclusion criteria:
- 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
Exclusion
Key Trial Info
Start Date :
June 2 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03376893
Start Date
June 2 2017
End Date
December 31 2026
Last Update
September 3 2025
Active Locations (4)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Washington University School of Medicine
St Louis, Missouri, United States, 63110
3
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-9000
4
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232