Sickle Cell DiseaseCRUISENCT02824406
Cerebrovascular Reserve Measurements in Sickle Cell Disease
An observational study of Sickle Cell Disease, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
The primary aim of this study is to evaluate MRI-based cerebrovascular reserve (CVR) measurements in adult patients with Sickle Cell Disease (SCD). The primary objective is to assess whether there is a correlation between CVR and silent cerebral infarcts (SCIs). 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
- What is being tested?
- Acetazolamide
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2014to Dec 2017
- 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: Patients are eligible if they have a diagnosis of sickle cell disease; either homozygous sickle cell disease (HbSS), or HbSβ0 thalassemia and are in a steady disease state i.e. no crisis requiring hospitalization 4 weeks prior to participation.
Who may be able to join
- Sickle cell disease; either homozygous sickle cell disease (HbSS), or HbSβ0 thalassemia
- 18 years of age or older
- Informed consent
- Similar ethnic background as Patient group
- 18 years of age or older
- Informed consent
Who cannot join
- Inability of the patient to provide informed consent or legally incompetent/incapacitated to do so
- Contraindications for MRI, such as pregnancy, claustrophobia or the presence of metal in the body
- Sickle cell crisis at the moment of participation
- History of cerebral pathology that compromises measurements, such as cerebral palsy, brain tumour,meningitis, overt infarct
- Brain surgery performed in the last 3 months
- Severe liver, heart or renal dysfunction (clearance < 10 mL/min)
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- Allergy to sulphonamide
- Breastfeeding
- Use of phenytoin, procaine or acetylsacylic acid ("Ascal/aspirin")
- Risk of hypokalaemia (use of diuretics, primary hyperaldosteronism)
- Addison's Disease
- Severe asthma or emphysema
Trial locations and contacts
1 site in 1 country.
BJ Biemond contact
Netherlands1 site, 1 recruiting
- Recruiting
Academic Medical Center
Amsterdam
A J Nederveen, dr. ir.
About this study
Official title: Cerebrovascular Reserve Measurements in Sickle Cell Disease: an MRI Study
The primary aim of this study is to evaluate MRI-based cerebrovascular reserve (CVR) measurements in adult patients with Sickle Cell Disease (SCD).
The primary objective is to assess whether there is a correlation between CVR and silent cerebral infarcts (SCIs).
Read the detailed description
CVR is hypothesized to be impaired in SCD patients and could account for the white matter hyperintensities seen on MRI in these patients. Cerebral blood flow (CBF) alone is not sufficient to provide insight into the hemodynamic status of the brain. CVR allows us to gain insight into the capacity of the cerebrovasculature to respond to increased CBF. Vasculopathy is common in SCD and the caliber of the vessels can be assessed with 4D Flow MRI in response to actue and chronic changes in the velocity and wall shear stress on the intracranial arteries in the Circle of Willis.
This study will be performed as a single center, patient-control, cross-sectional, observational study in patients with steady-state SCD and controls. The investigators expect that patients with impaired CVR will have a greater number and/or volume of SCIs.
- Conditions
- Sickle Cell Disease
- Being tested
- Acetazolamide
- Keywords
- Sickle Cell Anemia, Cerebrovascular Reserve, Perfusion, Vasculopathy, Magnetic Resonance Imaging
- Medical subject headings
- Anemia, Sickle Cell, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetazolamideDrug
Also called Diamox
Acetazolamide is administered to all participants to induce vasodilation, in order to assess the physiologic response on cerebral blood flow.
| Study group | Role | What they receive |
|---|---|---|
| Patients | CVR assessment consists of CBF measurement with arterial spin labelling (ASL)-MRI before and after intravenous administration of 16mg/kg acetazolamide (Diamox) Receives: Drug: Acetazolamide | |
| Controls | CVR assessment consists of CBF measurement with arterial spin labelling (ASL)-MRI before and after intravenous administration of 16mg/kg acetazolamide (Diamox) Receives: Drug: Acetazolamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebrovascular Reserve (CVR) from arterial spin labelling-MRI in patients compared to controls
Cerebral blood flow (CBF mL/100g/min) measurement before, during, and after, an intravenous administration of 16mg/kg acetazolamide. The percentage change in CBF will be used as a measure for CVR (%).
Measured: 20 minutes
Secondary outcomes (4)
Cerebral Metabolic Rate of Oxygen in patients and controls
Oxygen extraction fraction and cerebral blood flow are proportional to the cerebral metabolic rate of oxygen. Using the CBF from the primary outcome, and having measured the T2 of blood (which is dependent on oxygen), we can derive the oxygen extraction fraction, which allows us to calculate the cerebral metabolic rate of oxygen (CMRO2) and compare patients with controls.
Measured: 2 minutes
Blood markers relating to anemia will be related to MRI findings
Hematocrit, hemoglobin, hemolysis, red blood cell count, mean corpuscular hemoglobin concentration.
Measured: Through study completion, an average of 1 year
Velocity in the circle of willis assessed with 4D Flow MRI
Velocity (m/s) before and after acetazolamide challenge will be used to indicate cerebrovascular reserve and compared between patients and controls
Measured: 10 minutes
Silent Cerebral Infarct (SCI) on T2-weighted FLAIR MRI
Volume of SCIs will be assessed in relation to CVR
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study startAug 2014
- Primary completionJun 2017 (estimated)
- Study completionDec 2017 (estimated)
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 Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, B.J. Biemond, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- AJ Nederveen, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02824406
- Sponsor's protocol ID
- CRUISE study
- Acronym
- CRUISE
- Status last verified
- Jul 2016
- First submitted
- 9 Feb 2016
- Last updated
- 6 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebrovascular Reserve Measurements in Sickle Cell Disease: an MRI Study
- ClinicalTrials.gov ID
- NCT02824406
- Acronym / sponsor ID
- CRUISE / CRUISE study
- Conditions
- Sickle Cell Disease
- Keywords
- Sickle Cell Anemia, Cerebrovascular Reserve, Perfusion, Vasculopathy, Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- Aug 2014
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 6 Jul 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.
The primary aim of this study is to evaluate MRI-based cerebrovascular reserve (CVR) measurements in adult patients with Sickle Cell Disease (SCD).
The primary objective is to assess whether there is a correlation between CVR and silent cerebral infarcts (SCIs).
Detailed description
CVR is hypothesized to be impaired in SCD patients and could account for the white matter hyperintensities seen on MRI in these patients. Cerebral blood flow (CBF) alone is not sufficient to provide insight into the hemodynamic status of the brain. CVR allows us to gain insight into the capacity of the cerebrovasculature to respond to increased CBF. Vasculopathy is common in SCD and the caliber of the vessels can be assessed with 4D Flow MRI in response to actue and chronic changes in the velocity and wall shear stress on the intracranial arteries in the Circle of Willis.
This study will be performed as a single center, patient-control, cross-sectional, observational study in patients with steady-state SCD and controls. The investigators expect that patients with impaired CVR will have a greater number and/or volume of SCIs.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Drug: AcetazolamideCVR assessment consists of CBF measurement with arterial spin labelling (ASL)-MRI before and after intravenous administration of 16mg/kg acetazolamide (Diamox) |
| Controls | – | Drug: AcetazolamideCVR assessment consists of CBF measurement with arterial spin labelling (ASL)-MRI before and after intravenous administration of 16mg/kg acetazolamide (Diamox) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are eligible if they have a diagnosis of sickle cell disease; either homozygous sickle cell disease (HbSS), or HbSβ0 thalassemia and are in a steady disease state i.e. no crisis requiring hospitalization 4 weeks prior to participation.
Key inclusion criteria (6 listed)
- Sickle cell disease; either homozygous sickle cell disease (HbSS), or HbSβ0 thalassemia
- 18 years of age or older
- Informed consent
- Similar ethnic background as Patient group
- 18 years of age or older
Key exclusion criteria (12 listed)
- Inability of the patient to provide informed consent or legally incompetent/incapacitated to do so
- Contraindications for MRI, such as pregnancy, claustrophobia or the presence of metal in the body
- Sickle cell crisis at the moment of participation
- History of cerebral pathology that compromises measurements, such as cerebral palsy, brain tumour,meningitis, overt infarct
- Brain surgery performed in the last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcetazolamideAlso: DiamoxAcetazolamide is administered to all participants to induce vasodilation, in order to assess the physiologic response on cerebral blood flow. | Drug | Controls, Patients |
Primary outcome
Cerebrovascular Reserve (CVR) from arterial spin labelling-MRI in patients compared to controls
Time frame: 20 minutes
Cerebral blood flow (CBF mL/100g/min) measurement before, during, and after, an intravenous administration of 16mg/kg acetazolamide. The percentage change in CBF will be used as a measure for CVR (%).
4 secondary outcomes
Cerebral Metabolic Rate of Oxygen in patients and controls
Time frame: 2 minutes
Blood markers relating to anemia will be related to MRI findings
Time frame: Through study completion, an average of 1 year
Velocity in the circle of willis assessed with 4D Flow MRI
Time frame: 10 minutes
Silent Cerebral Infarct (SCI) on T2-weighted FLAIR MRI
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2016.
- Individual participant dataSharing planned: Yes
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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.
BJ Biemond contact
AJ Nederveen principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1 site 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 Disease, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 12 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: status not confirmed, as of the sponsor's last update on 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact BJ Biemond (b.j.biemond@amc.uva.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebrovascular Reserve (CVR) from arterial spin labelling-MRI in patients compared to controls (time frame: 20 minutes). 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 6 Jul 2016.