Establishment of Functional MRI Imaging Parameters for Us... | NCT02445144

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

NCT02445144

Sponsor

Albert Einstein College of Medicine

Status

Terminated

Last Update Posted

Dec 14, 2020Actual

Enrollment

26Actual

Phase

Not provided

Conditions

Sickle Cell Anemia

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

lack of funding

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

May 4, 2020Actual

Completion Date

May 4, 2020Actual

First Submitted Date

Apr 15, 2015

First Submission Date that Met QC Criteria

May 12, 2015

First Posted Date

May 15, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2020

Last Update Posted Date

Dec 14, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Henny Billett, Chief, Division of Hematology, Department of Medicine, Albert Einstein College of MedicinePrincipal Investigator

Lead Sponsor

Albert Einstein College of MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Cogstate Testing	Exploration of the association between CBF values and cognitive performance deficits	Day 1
Mean diffusivity/Fractional anisotropy (MD/FA) evaluated by diffusion tensor imaging (DTI) MRI measurements

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

18-55 year old male and female patients with sickle cell anemia who are asymptomatic of previous CNS disease

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Henny H Billett, MD	Montefiore Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Albert Einstein College of Medicine		The Bronx	New York	10461	United States
Montefiore Medical Center (Einstein)

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Data will be made available after manuscript publication to those that request it

Types

Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Time Frame

Time frame of study has ended. Only preliminary data will be available - no end date

Access Criteria

Other investigators

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000755	Anemia, Sickle Cell
D007249	Inflammation

Ancestor Terms

ID	Term
D000745	Anemia, Hemolytic, Congenital
D000743	Anemia, Hemolytic
D000740	Anemia
D006402	Hematologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided