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.
Brief Title
Establishment of Functional MRI Imaging Parameters for Use in the Evaluation of Sickle Cell Disease
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.
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.
Completion Date
Completion Date Type
Actual
Conditions
Sickle Cell Anemia
Eligibility Criteria
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
* 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
Inclusion Criteria
Inclusion Criteria:
* Patient with HbSS/HbSB0,
* age between 18 and 55 years or age/gender/race/education matched peer
* Patient with HbSS/HbSB0,
* age between 18 and 55 years or age/gender/race/education matched peer
Gender
All
Gender Based
false
Keywords
Inflammation
Blood Flow
Cognition
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
55 Years
Minimum Age
18 Years
NCT Id
NCT02445144
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2014-3574
Overall Status
Terminated
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Establishment of Functional MRI Imaging Parameters for Use in the Evaluation of Sickle Cell Disease
Primary Outcomes
Outcome Description
CBF will be measured by continuous arterial spin labeling (CASL) MRI
Outcome Measure
Cerebral blood flow (CBF) measured by continuous arterial spin labeling (CASL) MRI
Outcome Time Frame
Day 1
Secondary Outcomes
Outcome Description
Exploration of the association between CBF values and cognitive performance deficits
Outcome Time Frame
Day 1
Outcome Measure
Cogstate Testing
Outcome Description
MD/FA will be evaluated by diffusion tensor imaging (DTI) MRI measurements
Outcome Time Frame
Day 1
Outcome Measure
Mean diffusivity/Fractional anisotropy (MD/FA) evaluated by diffusion tensor imaging (DTI) MRI measurements
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
18-55 year old male and female patients with sickle cell anemia who are asymptomatic of previous CNS disease
Std Ages
Adult
Maximum Age Number (converted to Years and rounded down)
55
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Henny Billett
Investigator Email
hbillett@montefiore.org
Investigator Phone
718-920-6310