Cerebrovascular Reserve Measurements in Sickle Cell Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2017-12-31

Brief Summary

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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).

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Detailed Description

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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

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Sickle Cell Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients

CVR assessment consists of CBF measurement with arterial spin labelling (ASL)-MRI before and after intravenous administration of 16mg/kg acetazolamide (Diamox)

Acetazolamide

Intervention Type DRUG

Acetazolamide is administered to all participants to induce vasodilation, in order to assess the physiologic response on cerebral blood flow.

Controls

CVR assessment consists of CBF measurement with arterial spin labelling (ASL)-MRI before and after intravenous administration of 16mg/kg acetazolamide (Diamox)

Acetazolamide

Intervention Type DRUG

Acetazolamide is administered to all participants to induce vasodilation, in order to assess the physiologic response on cerebral blood flow.

Interventions

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Acetazolamide

Acetazolamide is administered to all participants to induce vasodilation, in order to assess the physiologic response on cerebral blood flow.

Intervention Type DRUG

Other Intervention Names

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Diamox

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes