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Neurovascular Determinants of Cognitive Function in Adults With Sickle Cell Disease

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ClinicalTrials.gov Identifier: NCT02946905
Recruitment Status : Enrolling by invitation
First Posted : October 27, 2016
Last Update Posted : May 27, 2021
Sponsor:
Information provided by (Responsible Party):
Enrico M Novelli, University of Pittsburgh

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
Sickle Cell Disease

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.

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Study Type : Observational
Estimated 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 : April 2016
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Group/Cohort
SCD participant
No intervention
Non-SCD participant
No intervention



Primary Outcome Measures :
  1. 7 Tesla MRI [ Time Frame: 5 years ]
    Multiple conventional and novel markers of small vessel disease will be evaluated.


Secondary Outcome Measures :
  1. Inflammation [ Time Frame: 5 years ]
    Blood biomarkers of inflammation will be collected

  2. Oxidative markers [ Time Frame: 5 years ]
    Blood biomarkers of oxidative markers will be collected.


Biospecimen Retention:   Samples Without DNA
blood biomarkers of inflammation and oxidative damage


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
150 participants with Sickle Cell Disease (SCD) 50 participants without Sickle Cell Disease
Criteria

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:

    1. Diabetes mellitus
    2. Coronary artery disease
    3. Peripheral vascular disease
    4. Other causes of cerebral vasculitis such as Systemic Lupus Erythematosus (SLE)
  4. Any contraindication to MRI scanning including:

    1. History of claustrophobia
    2. 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)
    3. Any known metal fragments embedded in the body (eg: ear implant)
    4. Neural stimulator (e.g. Transcutaneous Electrical Nerve Stimulation Unit)
    5. Metal in the eye (e.g. from machining)
    6. Any metallic foreign body, shrapnel, or bullet
    7. Inability to lie still for 30 minutes or more
  5. Inability to provide direct consent
  6. In a current medical or pain crisis as diagnosed by attending physician -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02946905


Sponsors and Collaborators
University of Pittsburgh
Investigators
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Principal Investigator: Enrico Novelli, MD University of Pittsburgh
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Responsible Party: Enrico M Novelli, Assistant Professor of Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02946905    
Other Study ID Numbers: 12040139
First Posted: October 27, 2016    Key Record Dates
Last Update Posted: May 27, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn