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Trial record 47 of 696 for:    Sickle Cell Disease

Cerebrovascular Reserve Measurements in Sickle Cell Disease (CRUISE)

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ClinicalTrials.gov Identifier: NCT02824406
Recruitment Status : Unknown
Verified July 2016 by B.J. Biemond, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Recruitment status was:  Recruiting
First Posted : July 6, 2016
Last Update Posted : July 6, 2016
Sponsor:
Information provided by (Responsible Party):
B.J. Biemond, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief 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).


Condition or disease Intervention/treatment
Sickle Cell Disease Drug: Acetazolamide

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.


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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Cerebrovascular Reserve Measurements in Sickle Cell Disease: an MRI Study
Study Start Date : August 2014
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017


Group/Cohort Intervention/treatment
Patients
CVR assessment consists of CBF measurement with arterial spin labelling (ASL)-MRI before and after intravenous administration of 16mg/kg acetazolamide (Diamox)
Drug: Acetazolamide
Acetazolamide is administered to all participants to induce vasodilation, in order to assess the physiologic response on cerebral blood flow.
Other Name: Diamox

Controls
CVR assessment consists of CBF measurement with arterial spin labelling (ASL)-MRI before and after intravenous administration of 16mg/kg acetazolamide (Diamox)
Drug: Acetazolamide
Acetazolamide is administered to all participants to induce vasodilation, in order to assess the physiologic response on cerebral blood flow.
Other Name: Diamox




Primary Outcome Measures :
  1. 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 (%).


Secondary Outcome Measures :
  1. Cerebral Metabolic Rate of Oxygen in patients and controls [ Time Frame: 2 minutes ]
    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.

  2. Blood markers relating to anemia will be related to MRI findings [ Time Frame: Through study completion, an average of 1 year ]
    Hematocrit, hemoglobin, hemolysis, red blood cell count, mean corpuscular hemoglobin concentration.

  3. Velocity in the circle of willis assessed with 4D Flow MRI [ Time Frame: 10 minutes ]
    Velocity (m/s) before and after acetazolamide challenge will be used to indicate cerebrovascular reserve and compared between patients and controls

  4. Silent Cerebral Infarct (SCI) on T2-weighted FLAIR MRI [ Time Frame: 10 minutes ]
    Volume of SCIs will be assessed in relation to CVR


Biospecimen Retention:   Samples Without DNA
The following outcomes will be assessed from veinous-drawn blood samples: Sodium, Potassium, Creatinine, Bilirubin, ASAT(SGOT), ALAT (SGPT), LDH, Ferritin, Haptoglobin, Hemoglobin, Erythrocytes, Leukocytes, Thrombocytes, MCV, MCH, MCHC, RDW, Hemoglobin, Hematocrit, Hb-F, Hb-A2, Hb-S, Hb-A2, Reticulocytes, Lymphocytes, ADAMTS13, D-Dimer, von Willebrand activity / antigen / multimer, hs-CRP, F1+2, PAI-1 antigen, t-PA-Ag antigen, NETs, Circulating histones, Metalloproteinase, Interleukin 6,13 and 18, Free HB, ADMA asymmetric dimethylarginine, VCAM, ICAM, AGEs:Pentosidine, CML - carboxyl methyl lysine, Thrombospondin, GFAP, L-selectin, VEGF, Pentraxine-3


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria Patient group:

  • Sickle cell disease; either homozygous sickle cell disease (HbSS), or HbSβ0 thalassemia
  • 18 years of age or older
  • Informed consent

Inclusion Criteria Control group:

  • Similar ethnic background as Patient group
  • 18 years of age or older
  • Informed consent

Exclusion Criteria Patient group and Control group:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824406


Contacts
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Contact: BJ Biemond b.j.biemond@amc.uva.nl

Locations
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Netherlands
Academic Medical Center Recruiting
Amsterdam, Netherlands
Principal Investigator: A J Nederveen, dr. ir.         
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
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Principal Investigator: AJ Nederveen Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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Responsible Party: B.J. Biemond, Dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT02824406     History of Changes
Other Study ID Numbers: CRUISE study
First Posted: July 6, 2016    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by B.J. Biemond, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Sickle Cell Anemia
Cerebrovascular Reserve
Perfusion
Vasculopathy
Magnetic Resonance Imaging
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Hematologic Diseases
Genetic Diseases, Inborn
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hemoglobinopathies
Acetazolamide
Anticonvulsants
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs