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

Terminated

• Conditions: Sickle Cell Anemia

• Registration Number: NCT02445144
• Lead Sponsor: Albert Einstein College of Medicine

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.

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 Timeline

• Study Start: 2014-11
• Study First Submitted: 2015-04-15
• Study First Submitted QC: 2015-05-12
• Study First Posted: 2015-05-15
• Primary Completion: 2020-05-04
• Study Completion: 2020-05-04
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Cogstate Testing	Day 1	Exploration of the association between CBF values and cognitive performance deficits
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

Trial Locations

Locations (2)

Albert Einstein College of Medicine; 🇺🇸 Bronx, New York, United States

Montefiore Medical Center (Einstein); 🇺🇸 Bronx, New York, United States