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Establishment of Functional MRI Imaging Parameters for Use in the Evaluation of Sickle Cell Disease

Sponsor
Albert Einstein College of Medicine (Other)
Overall Status
Terminated
CT.gov ID
NCT02445144
Collaborator
(none)
26
Enrollment
2
Locations
66.1
Duration (Months)
13
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Patients with sickle cell anemia (SCA) are at an increased risk for damage to brain tissue due to their disease. The investigators are interested in how blood flow and cerebral inflammation are different in SCA patients and how that affects brain tissue- the investigators will use a relatively new set of dynamic MRI techniques to evaluate these parameters. The investigators will image participants with both SCA and matched controls with non-invasive MRI.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Patients with sickle cell anemia (SCA) are at increased risk for episodes of stroke, both overt clinically evident and subclinical lesions only seen on imaging, which have associated morbidity and mortality. In addition, SCA patients demonstrate relatively poorer cognitive performance compared to their peers without SCA that is believed to be related to the episodes of stroke, but may be present even in their absence.

    This study is designed to explore potential risk factors in patients with SCA that will identify predictors of cerebral damage that may also be modifiable. Elevated blood flow in cerebral arteries and increased inflammation are believed to be related to both ischemic lesions and cognitive findings but have not yet been clearly proven. We aim to use new MRI techniques which target cerebral blood flow and inflammation to identify differences in SCA patients and peers and follow this with an initial exploration of the association between these pathologic findings and cognitive deficits.

    The investigator does not assign specific interventions to the subjects of the study.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    26 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Establishment of Functional MRI Imaging Parameters for Use in the Evaluation of Sickle Cell Disease
    Study Start Date :
    Nov 1, 2014
    Actual Primary Completion Date :
    May 4, 2020
    Actual Study Completion Date :
    May 4, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    SCA Patients

    Asymptomatic sickle cell anemia patients will undergo imaging/neurocognitive testing and be compared to controls
    Control Patients

    Asymptomatic sickle cell anemia patients will undergo imaging/neurocognitive testing and be compared to controls

    Outcome Measures

    Primary Outcome Measures

    1. Cerebral blood flow (CBF) measured by continuous arterial spin labeling (CASL) MRI [Day 1]

      CBF will be measured by continuous arterial spin labeling (CASL) MRI

    Secondary Outcome Measures

    1. Cogstate Testing [Day 1]

      Exploration of the association between CBF values and cognitive performance deficits

    2. Mean diffusivity/Fractional anisotropy (MD/FA) evaluated by diffusion tensor imaging (DTI) MRI measurements [Day 1]

      MD/FA will be evaluated by diffusion tensor imaging (DTI) MRI measurements

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Patient with HbSS/HbSB0,

    • age between 18 and 55 years or age/gender/race/education matched peer

    Exclusion Criteria:

    • Previous history of a stroke/transient ischemic attack,

    • neurosurgery,

    • head trauma,

    • seizures,

    • pulmonary embolism,

    • deep-vein thrombosis,

    • bleeding/clotting disorders,

    • current or previous use of anticoagulation medications

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Albert Einstein College of Medicine Bronx New York United States 10461
    2 Montefiore Medical Center (Einstein) Bronx New York United States 10461

    Sponsors and Collaborators

    • Albert Einstein College of Medicine

    Investigators

    • Principal Investigator: Henny H Billett, MD, Montefiore Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Henny Billett, Chief, Division of Hematology, Department of Medicine, Albert Einstein College of Medicine
    ClinicalTrials.gov Identifier:
    NCT02445144
    Other Study ID Numbers:
    • 2014-3574
    First Posted:
    May 15, 2015
    Last Update Posted:
    Dec 14, 2020
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Henny Billett, Chief, Division of Hematology, Department of Medicine, Albert Einstein College of Medicine
    Inflammation
    Blood Flow
    Cognition
    Additional relevant MeSH terms:
    Anemia, Sickle Cell

    Study Results

    No Results Posted as of Dec 14, 2020