Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02445144
Recruitment Status : Active, not recruiting
First Posted : May 15, 2015
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Henny Billett, Albert Einstein College of Medicine

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.

Condition or disease
Sickle Cell Anemia

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.


Layout table for study information
Study Type : Observational
Actual Enrollment : 26 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Establishment of Functional MRI Imaging Parameters for Use in the Evaluation of Sickle Cell Disease
Study Start Date : November 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Cerebral blood flow (CBF) measured by continuous arterial spin labeling (CASL) MRI [ Time Frame: Day 1 ]
    CBF will be measured by continuous arterial spin labeling (CASL) MRI


Secondary Outcome Measures :
  1. Cogstate Testing [ Time Frame: Day 1 ]
    Exploration of the association between CBF values and cognitive performance deficits

  2. Mean diffusivity/Fractional anisotropy (MD/FA) evaluated by diffusion tensor imaging (DTI) MRI measurements [ Time Frame: Day 1 ]
    MD/FA will be evaluated by diffusion tensor imaging (DTI) MRI measurements


Biospecimen Retention:   Samples With DNA
Blood samples for evaluation of inflammatory markers


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02445144


Locations
Layout table for location information
United States, New York
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Montefiore Medical Center (Einstein)
Bronx, New York, United States, 10461
Sponsors and Collaborators
Albert Einstein College of Medicine
Investigators
Layout table for investigator information
Principal Investigator: Henny H Billett, MD Montefiore Medical Center

Layout table for additonal information
Responsible Party: Henny Billett, Chief, Division of Hematology, Department of Medicine, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT02445144     History of Changes
Other Study ID Numbers: 2014-3574
First Posted: May 15, 2015    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be made available after manuscript publication to those that request it

Keywords provided by Henny Billett, Albert Einstein College of Medicine:
Inflammation
Blood Flow
Cognition

Additional relevant MeSH terms:
Layout table for MeSH terms
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn