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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    Page 1 of 1 (4 locations)

    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