Sickle Cell AnemiaNCT02445144
Establishment of Functional MRI Imaging Parameters for Use in the Evaluation of Sickle Cell Disease
An observational study of Sickle Cell Anemia, run by Albert Einstein College of Medicine at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Anemia
- How many people
- 26 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2014to 4 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 18-55 year old male and female patients with sickle cell anemia who are asymptomatic of previous CNS disease
Who may be able to join
- Patient with HbSS/HbSB0,
- age between 18 and 55 years or age/gender/race/education matched peer
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Albert Einstein College of Medicine
The Bronx, New York, 10461
Montefiore Medical Center (Einstein)
The Bronx, New York, 10461
About this study
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.
Read the 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.
- Conditions
- Sickle Cell Anemia
- Keywords
- Inflammation, Blood Flow, Cognition
- Medical subject headings
- Anemia, Sickle Cell, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral blood flow (CBF) measured by continuous arterial spin labeling (CASL) MRI
CBF will be measured by continuous arterial spin labeling (CASL) MRI
Measured: Day 1
Secondary outcomes (2)
Cogstate Testing
Exploration of the association between CBF values and cognitive performance deficits
Measured: Day 1
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
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study startNov 2014
- Primary completion4 May 2020
- Study completion4 May 2020
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henny Billett, Albert Einstein College of Medicine
- Investigators
- Henny H Billett, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02445144
- Sponsor's protocol ID
- 2014-3574
- Status last verified
- Dec 2020
- First submitted
- 15 Apr 2015
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be made available after manuscript publication to those that request it
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Functional MRI Imaging Parameters for Use in the Evaluation of Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT02445144
- Acronym / sponsor ID
- 2014-3574
- Conditions
- Sickle Cell Anemia
- Keywords
- Inflammation, Blood Flow, Cognition
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: lack of funding
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- 4 May 2020 (actual)
- Study completion
- 4 May 2020 (actual)
- First posted
- 15 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 18-55 year old male and female patients with sickle cell anemia who are asymptomatic of previous CNS disease
Key inclusion criteria (2 listed)
- Patient with HbSS/HbSB0,
- age between 18 and 55 years or age/gender/race/education matched peer
Key exclusion criteria (8 listed)
- Previous history of a stroke/transient ischemic attack,
- neurosurgery,
- head trauma,
- seizures,
- pulmonary embolism,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Cogstate Testing
Time frame: Day 1
Mean diffusivity/Fractional anisotropy (MD/FA) evaluated by diffusion tensor imaging (DTI) MRI measurements
Time frame: Day 1
Results and safety
The study was stopped early (reason given: lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2020.
- Individual participant dataSharing planned: Yes. Data will be made available after manuscript publication to those that request it
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henny H Billett, MD principal investigator
Montefiore Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Anemia, run by Albert Einstein College of Medicine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: lack of funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral blood flow (CBF) measured by continuous arterial spin labeling (CASL) MRI (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2020.