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

Sickle Cell Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02445144
• Other study ID #: 2014-3574
• Status: Terminated
• Start date: November 2014
• Est. completion date: May 4, 2020

Study information

• Verified date: December 2020
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: May 4, 2020
• Est. primary completion date: May 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Anemia

Locations

Country	Name	City	State
United States	Albert Einstein College of Medicine	Bronx	New York
United States	Montefiore Medical Center (Einstein)	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral blood flow (CBF) measured by continuous arterial spin labeling (CASL) MRI	CBF will be measured by continuous arterial spin labeling (CASL) MRI	Day 1
Secondary	Cogstate Testing	Exploration of the association between CBF values and cognitive performance deficits	Day 1
Secondary	Mean diffusivity/Fractional anisotropy (MD/FA) evaluated by diffusion tensor imaging (DTI) MRI measurements	MD/FA will be evaluated by diffusion tensor imaging (DTI) MRI measurements	Day 1