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

NCT02445144 | Terminated

• 1 other identifier: 2014-3574
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 2

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.

Conditions

Sickle Cell Anemia

Keywords

Inflammation; Blood Flow; Cognition

Outcome Measures

Primary Outcomes (1)

• Cerebral blood flow (CBF) measured by continuous arterial spin labeling (CASL) MRI

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

  Day 1

Secondary Outcomes (2)

• Cogstate Testing

  Day 1

• Mean diffusivity/Fractional anisotropy (MD/FA) evaluated by diffusion tensor imaging (DTI) MRI measurements

  Day 1

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

18-55 year old male and female patients with sickle cell anemia who are asymptomatic of previous CNS disease

You may qualify if:

• Patient with HbSS/HbSB0,
• age between 18 and 55 years or age/gender/race/education matched peer

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead

Study Sites (2)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

Montefiore Medical Center (Einstein)

The Bronx, New York, 10461, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples for evaluation of inflammatory markers

MeSH Terms

Conditions

Anemia, Sickle Cell; Inflammation

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; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Henny H Billett, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Hematology, Department of Medicine

Study Record Dates

• First Submitted: April 15, 2015
• First Posted: May 15, 2015
• Study Start: November 1, 2014
• Primary Completion: May 4, 2020
• Study Completion: May 4, 2020
• Last Updated: December 14, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Time frame of study has ended. Only preliminary data will be available - no end date
• Access Criteria: Other investigators

Locations

US (2)