Clinical trial NCT02445144: Establishment of Functional MRI Imaging Parameters for Use in the Evaluation of Sickle Cell Disease
Official title: Establishment of Functional MRI Imaging Parameters for Use in the Evaluation of Sickle Cell Disease
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Sickle Cell Anemia
Keywords: Inflammation
Blood Flow
Cognition
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
First posted: 2015-05-15
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: Cerebral blood flow (CBF) measured by continuous arterial spin labeling (CASL) MRI
timeFrame: Day 1
Secondary outcomes:
measure: Cogstate Testing
timeFrame: Day 1
measure: Mean diffusivity/Fractional anisotropy (MD/FA) evaluated by diffusion tensor imaging (DTI) MRI measurements
timeFrame: Day 1
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center (Einstein)
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Henny H Billett, MD
role: PRINCIPAL_INVESTIGATOR
References: