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NCT Number: NCT02946905

Neurovascular Determinants of Cognitive Function in Adults With Sickle Cell Disease

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.

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 and above
  • Able to provide informed consent

For Non-SCD :

  • Between age 18 and 55
  • Able to provide informed consent
  • Are age, race, and gender matched to a Sickle Cell Disease study subject.

Exclusion criteria

  • Age less than 18 years
  • Current pregnancy or lactation
  • Any medical condition that may result in neurocognitive or brain dysfunction that is not secondary to SCD including:
  • Diabetes mellitus
  • Coronary artery disease
  • Peripheral vascular disease
  • Other causes of cerebral vasculitis such as Systemic Lupus Erythematosus (SLE)
  • Any contraindication to MRI scanning including:
  • History of claustrophobia
  • 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)
  • Any known metal fragments embedded in the body (eg: ear implant)
  • Neural stimulator (e.g. Transcutaneous Electrical Nerve Stimulation Unit)
  • Metal in the eye (e.g. from machining)
  • Any metallic foreign body, shrapnel, or bullet
  • Inability to lie still for 30 minutes or more
  • Inability to provide direct consent
  • In a current medical or pain crisis as diagnosed by attending physician -

Treatment and study plan

Primary outcomes

  1. 7 Tesla MRI

    Time frame: 5 years

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

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Oct 27, 2016
Registry last updated
May 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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