Epidemiology of Silent and Overt Strokes in Sickle Cell Anemia | Recruiting
Epidemiology of Silent and Overt St... | Recruiting
Epidemiology of Silent and Overt Strokes in Sickle Cell Anemia

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Medical Conditions
  • Anemia, Sickle Cell
  • Sickle Cell Disease
  • Stroke
  • Sickle Cell Thalassemia
  • Sickle Cell-Beta0-Thalassemia
Primary Contact Details
Recruitment Status
Recruiting
Trial source and source ID number
NCT03376893
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Summary
Sickle cell anemia is a rare disease occurring in an estimated 66,000 children and adults, often poor and underserved, in the United States. Strokes and silent strokes contribute significantly to illness burden in adults with sickle cell anemia, resulting in impairment, challenges with school and job performance, and premature death. Five NIH studies have identified therapies to prevent overt and silent strokes in children with sickle cell anemia, including monthly blood transfusion therapy (for preventing initial and recurrent strokes) and hydroxyurea (for preventing initial strokes). However, no stroke trials have established therapeutic approaches for adults with sickle cell anemia, despite the observation that at least 99% of children with sickle cell anemia 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). Strokes in adults with sickle cell anemia have simply not been well studied. Therapies applied in children may not be effective for stroke prevention in adults with sickle cell anemia. Identifying subgroups of adults with sickle cell anemia and higher incidence coupled with the contribution of established stroke risk factors in the general population (smoking, diabetes, obesity, renal disease) will provide the prerequisite data required for the first ever phase III clinical trials focused on secondary stroke prevention in adults. In six adult sickle cell disease centers, the investigators will conduct a prospective cohort study to test the primary hypothesis that the incidence of stroke recurrence in adults with silent strokes treated with hydroxyurea will be greater than in those without strokes treated with hydroxyurea. We will test two secondary hypotheses: 1) adults with sickle cell anemia and silent strokes have cognitive deficits when compared to adults with sickle cell anemia without silent strokes; and 2) adults with sickle cell anemia and strokes receiving regular blood transfusion will have a higher incidence of stroke recurrence than adults with sickle cell anemia without strokes. We will recruit at least 72 individuals with sickle cell anemia and history of silent stroke receiving hydroxyurea therapy, at least 72 individuals with sickle cell anemia and no history of stroke, and at least 50 individuals with sickle cell anemia and history of overt stroke receiving transfusion therapy.
Research Details
    Sorry, this information is not available
Phase
Sorry, this information is not available
Study Design
Sorry, this information is not available
Study Type
Observational
Intervention
Sorry, this information is not available
Intervention Type
See Interventions above
Primary Outcome Measures
    Adjudication of silent stroke in those with reported history of silent stroke and hydroxyurea therapy; Study enrollment; Adjudication of new strokes in those with history of silent stroke and on hydroxyurea therapy; Every 12 to 18 months after enrollment; Adjudication of new strokes in those with history of silent stroke and on hydroxyurea therapy; At study exit (at least 3.5 years after enrollment)
Secondary Outcome Measures
    Cognitive morbidity in those with silent or overt stroke; Study enrollment; Cognitive morbidity in those with silent or overt stroke; Every 12 to 18 months after enrollment; Cognitive morbidity in those with silent or overt stroke; At study exit (at least 3.5 years after enrollment); Adjudication of overt stroke in those with reported history of overt stroke and on transfusion therapy; Study enrollment; Adjudication of new strokes in those with history of overt stroke and on transfusion therapy; Every 12 to 18 months after enrollment; Adjudication of new strokes in those with history of overt stroke and on transfusion therapy; At study exit (at least 3.5 years after enrollment)
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
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Gender
All
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
194
Participant Inclusion Criteria
    Inclusion Criteria:

    1. SCA confirmed on hemoglobin analysis or documentation of phenotype

    2. ≥ 18 years of age

    3. Followed regularly (≥ 3 clinic visits per year) in the hematology clinics and have demonstrated adherence to routine clinic visits and follow-up visits for ≥ 3 years

    4. Willing to be followed prospectively for a minimum of 3.5 years and agree to a standard care entry MRI/MRA, exit MRI/MRA, as well as MRI/MRA performed at 12 to 18 month intervals

    5. For participants with history of silent strokes: Participants with evidence of a prior cerebral infarction ≥ 3 mm in size based on MRI with ≥ 1.5T magnet

    6. For participants with history of silent strokes: no regular blood transfusion for > 6 months continuously

    7. For participants with history of silent strokes: are receiving hydroxyurea for at least six months on stable dose

    8. For participants with history of overt strokes: those receiving regular blood transfusion therapy defined as scheduled at least once every 6 weeks, with a goal to maintain HbS concentrations less than 30% for at least the first two years after the initial overt stroke, and less than 50% thereafter

    9. For participants with history of overt strokes: evidence based on neurological sequelae or MRI with at least 1.5T magnet

    Exclusion Criteria:

    1. Participants judged to be non-compliant by the hematologist based on previous experience in terms of clinic appointments and following medical advice

    2. Contraindications to MRI, including individuals with MRI-incompatible foreign metal objects

    3. Cirrhosis

    4. Known seropositivity for HIV

    5. End-stage renal disease (ESRD)

    6. Baseline oxygen requirement for oxygen saturation < 90% on room air due to chronic pulmonary disease

    7. Any baseline rheumatologic disease(s) associated with end-organ damage

    8. For participants with previous silent strokes: Receiving transfusion therapy
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
London
Trial Contact(s)
Primary Trial Contact
Casey M Babb, MS
615-875-8794
Other Trial Contacts
Brittany V Covert, MPH
615-343-4855
Countries Recruiting
United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
The Epidemiology of Silent and Overt Strokes in Adults With Sickle Cell Anemia: a Prospective Cohort Study
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
161434
Sponsor(s)
Vanderbilt University Medical Center
Key Dates

Recruitment Start Date

Jun 2017

Recruitment End Date

Oct 2020

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

08 Dec 2017

Date updated in source

18 Dec 2017