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

Albert Einstein College of Medicine logo

Albert Einstein College of Medicine

Status

Terminated

Conditions

Sickle Cell Anemia

Study type

Observational

Funder types

Other

Identifiers

NCT02445144
2014-3574

Details and patient eligibility

About

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.

Full 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.

Enrollment

26 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

26 participants in 2 patient groups

SCA Patients
Description:
Asymptomatic sickle cell anemia patients will undergo imaging/neurocognitive testing and be compared to controls
Control Patients
Description:
Asymptomatic sickle cell anemia patients will undergo imaging/neurocognitive testing and be compared to controls

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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