Neurovascular Determinants of Cognitive Function in Adults With Sickle Cell Disease

NCT02946905 | Completed

• 1 other identifier: 12040139
• Study Type: observational
• Target: 226
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (1)

• 7 Tesla MRI

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

  5 years

Secondary Outcomes (2)

• Inflammation

  5 years

• Oxidative markers

  5 years

Study Arms (2)

SCD participant

No intervention

Non-SCD participant

No intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

150 participants with Sickle Cell Disease (SCD) 50 participants without Sickle Cell Disease

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood biomarkers of inflammation and oxidative damage

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Enrico Novelli, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: September 26, 2016
• First Posted: October 27, 2016
• Study Start: April 1, 2016
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share