Neurovascular Determinants of Cognitive Function in Adults With Sickle Cell Disease

Sponsor
University of Pittsburgh (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT02946905
Collaborator
(none)
200
83

Study Details

Study Description

Brief Summary

Cognitive impairment is a poorly understood, serious, and emerging complication for adult patients with sickle cell disease. Because there is extensive microvascular damage from oxidative damage in sickle cell disease, the investigators hypothesize that this is also present in the cerebral microvasculature to cause cognitive impairment. The investigators plan to test this by correlating markers of inflammation and oxidative damage with cognitive performance and 7 Tesla brain MRI microvascular findings in these patients, with the long term goal of understanding the mechanisms and risk factors of cognitive impairment in sickle cell disease.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The Neurovascular Determinants of Cognitive Function in Adults with Sickle Cell Disease is a study for adults 18 and older who have been diagnosed with Sickle Cell Disease (SCD). Many adult patients with SCD suffer from cognitive impairment (CI), a serious complication responsible for severe functional limitations, and whose pathogenesis, risk factors, and natural history are unknown. This research project will look at cognitive performance and 7 Tesla brain MRI findings along with markers of inflammation and oxidation to better understand the mechanism and risk factors. The investigators will complete a baseline assessment. SCD participants will be seen for follow-up at 3 and 5 years. Non-SCD participants will be seen for follow-up at 3 years. All assessments are completed at no cost and there is compensation for participation.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Neurovascular Determinants of Cognitive Function in Adults With Sickle Cell Disease
    Study Start Date :
    Apr 1, 2016
    Anticipated Primary Completion Date :
    Mar 1, 2023
    Anticipated Study Completion Date :
    Mar 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    SCD participant

    No intervention

    Non-SCD participant

    No intervention

    Outcome Measures

    Primary Outcome Measures

    1. 7 Tesla MRI [5 years]

      Multiple conventional and novel markers of small vessel disease will be evaluated.

    Secondary Outcome Measures

    1. Inflammation [5 years]

      Blood biomarkers of inflammation will be collected

    2. Oxidative markers [5 years]

      Blood biomarkers of oxidative markers will be collected.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. Age 18 and above

    2. Able to provide informed consent

    For Non-SCD :
    1. Between age 18 and 55

    2. Able to provide informed consent

    3. Are age, race, and gender matched to a Sickle Cell Disease study subject.

    Exclusion Criteria:
    1. Age less than 18 years

    2. Current pregnancy or lactation

    3. Any medical condition that may result in neurocognitive or brain dysfunction that is not secondary to SCD including:

    4. Diabetes mellitus

    5. Coronary artery disease

    6. Peripheral vascular disease

    7. Other causes of cerebral vasculitis such as Systemic Lupus Erythematosus (SLE)

    8. Any contraindication to MRI scanning including:

    9. History of claustrophobia

    10. Presence of metallic implants such as cardiac pacemaker or implantable defibrillator, surgical aneurysm clips, or any implanted device (e.g. insulin pump, drug infusion device)

    11. Any known metal fragments embedded in the body (eg: ear implant)

    12. Neural stimulator (e.g. Transcutaneous Electrical Nerve Stimulation Unit)

    13. Metal in the eye (e.g. from machining)

    14. Any metallic foreign body, shrapnel, or bullet

    15. Inability to lie still for 30 minutes or more

    16. Inability to provide direct consent

    17. In a current medical or pain crisis as diagnosed by attending physician -

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Pittsburgh

    Investigators

    • Principal Investigator: Enrico Novelli, MD, University of Pittsburgh

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Enrico M Novelli, Assistant Professor of Medicine, University of Pittsburgh
    ClinicalTrials.gov Identifier:
    NCT02946905
    Other Study ID Numbers:
    • 12040139
    First Posted:
    Oct 27, 2016
    Last Update Posted:
    Apr 8, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 8, 2022