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

NCT ID: NCT02445144

Last Updated: 2020-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2020-05-04

Brief Summary

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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

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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.

Conditions

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Sickle Cell Anemia

Keywords

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Inflammation Blood Flow Cognition

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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SCA Patients

Asymptomatic sickle cell anemia patients will undergo imaging/neurocognitive testing and be compared to controls

No interventions assigned to this group

Control Patients

Asymptomatic sickle cell anemia patients will undergo imaging/neurocognitive testing and be compared to controls

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Albert Einstein College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Henny Billett

Chief, Division of Hematology, Department of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Henny H Billett, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

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Albert Einstein College of Medicine

The Bronx, New York, United States

Site Status

Montefiore Medical Center (Einstein)

The Bronx, New York, United States

Site Status

Countries

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United States

Other Identifiers

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2014-3574

Identifier Type: -

Identifier Source: org_study_id