Sickle Cell DiseaseNCT02946905
Neurovascular Determinants of Cognitive Function in Adults With Sickle Cell Disease
An observational study of Sickle Cell Disease, run by University of Pittsburgh.
Trial summary
Cognitive impairment is a poorly understood, serious, and emerging complication for adult patients with sickle cell disease. Because there is extensive microvascular damage from oxidative damage in sickle cell disease, the investigators hypothesize that this is also present in the cerebral microvasculature to cause… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Disease
- How many people
- 226 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to 31 Mar 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 150 participants with Sickle Cell Disease (SCD) 50 participants without Sickle Cell Disease
Who may be able to join
- Age 18 and above
- Able to provide informed consent
- For Non-SCD :
- Between age 18 and 55
- Able to provide informed consent
- Are age, race, and gender matched to a Sickle Cell Disease study subject.
Who cannot join
- Age less than 18 years
- Current pregnancy or lactation
- Any medical condition that may result in neurocognitive or brain dysfunction that is not secondary to SCD including:
- Diabetes mellitus
- Coronary artery disease
- Peripheral vascular disease
Show all 17Show fewer
- Other causes of cerebral vasculitis such as Systemic Lupus Erythematosus (SLE)
- Any contraindication to MRI scanning including:
- History of claustrophobia
- Presence of metallic implants such as cardiac pacemaker or implantable defibrillator, surgical aneurysm clips, or any implanted device (e.g. insulin pump, drug infusion device)
- Any known metal fragments embedded in the body (eg: ear implant)
- Neural stimulator (e.g. Transcutaneous Electrical Nerve Stimulation Unit)
- Metal in the eye (e.g. from machining)
- Any metallic foreign body, shrapnel, or bullet
- Inability to lie still for 30 minutes or more
- Inability to provide direct consent
- In a current medical or pain crisis as diagnosed by attending physician -
About this study
Cognitive impairment is a poorly understood, serious, and emerging complication for adult patients with sickle cell disease. Because there is extensive microvascular damage from oxidative damage in sickle cell disease, the investigators hypothesize that this is also present in the cerebral microvasculature to cause cognitive impairment. The investigators plan to test this by correlating markers of inflammation and oxidative damage with cognitive performance and 7 Tesla brain MRI microvascular findings in these patients, with the long term goal of understanding the mechanisms and risk factors of cognitive impairment in sickle cell disease.
Read the detailed description
The Neurovascular Determinants of Cognitive Function in Adults with Sickle Cell Disease is a study for adults 18 and older who have been diagnosed with Sickle Cell Disease (SCD). Many adult patients with SCD suffer from cognitive impairment (CI), a serious complication responsible for severe functional limitations, and whose pathogenesis, risk factors, and natural history are unknown. This research project will look at cognitive performance and 7 Tesla brain MRI findings along with markers of inflammation and oxidation to better understand the mechanism and risk factors. The investigators will complete a baseline assessment. SCD participants will be seen for follow-up at 3 and 5 years. Non-SCD participants will be seen for follow-up at 3 years. All assessments are completed at no cost and there is compensation for participation.
- Conditions
- Sickle Cell Disease
- Medical subject headings
- Anemia, Sickle Cell
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 |
|---|---|---|
| SCD participant | No intervention | |
| Non-SCD participant | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
7 Tesla MRI
Multiple conventional and novel markers of small vessel disease will be evaluated.
Measured: 5 years
Secondary outcomes (2)
Inflammation
Blood biomarkers of inflammation will be collected
Measured: 5 years
Oxidative markers
Blood biomarkers of oxidative markers will be collected.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study startApr 2016
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrico M Novelli, University of Pittsburgh
- Investigators
- Enrico Novelli, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946905
- Sponsor's protocol ID
- 12040139
- Status last verified
- Apr 2023
- First submitted
- 26 Sep 2016
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurovascular Determinants of Cognitive Function in Adults With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT02946905
- Acronym / sponsor ID
- 12040139
- Conditions
- Sickle Cell Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 27 Oct 2016 (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.
Cognitive impairment is a poorly understood, serious, and emerging complication for adult patients with sickle cell disease. Because there is extensive microvascular damage from oxidative damage in sickle cell disease, the investigators hypothesize that this is also present in the cerebral microvasculature to cause cognitive impairment. The investigators plan to test this by correlating markers of inflammation and oxidative damage with cognitive performance and 7 Tesla brain MRI microvascular findings in these patients, with the long term goal of understanding the mechanisms and risk factors of cognitive impairment in sickle cell disease.
Detailed description
The Neurovascular Determinants of Cognitive Function in Adults with Sickle Cell Disease is a study for adults 18 and older who have been diagnosed with Sickle Cell Disease (SCD). Many adult patients with SCD suffer from cognitive impairment (CI), a serious complication responsible for severe functional limitations, and whose pathogenesis, risk factors, and natural history are unknown. This research project will look at cognitive performance and 7 Tesla brain MRI findings along with markers of inflammation and oxidation to better understand the mechanism and risk factors. The investigators will complete a baseline assessment. SCD participants will be seen for follow-up at 3 and 5 years. Non-SCD participants will be seen for follow-up at 3 years. All assessments are completed at no cost and there is compensation for participation.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCD participant | – | –No intervention |
| Non-SCD participant | – | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 150 participants with Sickle Cell Disease (SCD) 50 participants without Sickle Cell Disease
Key inclusion criteria (6 listed)
- Age 18 and above
- Able to provide informed consent
- Between age 18 and 55
- Able to provide informed consent
- Are age, race, and gender matched to a Sickle Cell Disease study subject.
Key exclusion criteria (17 listed)
- Age less than 18 years
- Current pregnancy or lactation
- Any medical condition that may result in neurocognitive or brain dysfunction that is not secondary to SCD including:
- Any contraindication to MRI scanning including:
- Inability to provide direct consent
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
7 Tesla MRI
Time frame: 5 years
Multiple conventional and novel markers of small vessel disease will be evaluated.
2 secondary outcomes
Inflammation
Time frame: 5 years
Oxidative markers
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Individual participant dataSharing planned: No
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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.
Enrico Novelli, MD principal investigator
University of Pittsburgh
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease, run by University of Pittsburgh.
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 6 inclusion and 17 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: finished, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
7 Tesla MRI (time frame: 5 years). 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 1 May 2023.