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ISRCTN
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ISRCTN75786983
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ClinicalTrials.gov identifier
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Public title
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Cerebral venous drainage in multiple sclerosis
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Scientific title
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Cerebral venous drainage in multiple sclerosis: protocol for a blinded, age-sex matched cross-sectional ultrasound study
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Acronym
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N/A
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Serial number at source
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11/LO/1139
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Study hypothesis
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There will be statistically and clinically significant differences in cerebral venous outflow disturbance between multiple sclerosis patients and healthy controls.
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Lay summary
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Lay summary under review
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Ethics approval
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UK National Research Ethics Board approved on 15th August 2011, ref: 11/LO/1139
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Study design
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Sonographer blinded age-sex healthy control matched cross-sectional ultrasound study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Multiple sclerosis
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Participants - inclusion criteria
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1. 18 years of age or greater
2. Informed consent
3. Cases: multiple sclerosis by McDonald criteria with estimated disease severity score < 6, any disease pattern
4. Controls: no other relevant health condition
5. Ability to perform Valsalva manoeuvre
6. Stable disease for one month pre-recruitment
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Participants - exclusion criteria
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1. Concurrent enrolment in multiple sclerosis drug trial
2. Concurrent masking neurological disease
3. Pregnancy
4. Inability to lie supine
5. Intercurrent infection
6. Superior vena cava obstruction
7. Tricuspid regurgitation
8. Right heart failure
9. Vasculitis
10. Treatment with venodilators (e.g. nitrates)
11. Head and neck surgery or radiotherapy
12. Previous central venous catheterisation
13. Previous central venous thrombosis
14. Thrombophilia
15. Arrhythmia on baseline electrocardiogram (ECG)
16. Postural systolic drop of >30mmHg on standing
17. Steroid treatment within one month
18. Pulmonary hypertension
19. Malignancy
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Anticipated start date
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01/11/2011
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Anticipated end date
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01/11/2012
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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60
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Interventions
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All participants will undergo a lying and standing blood pressure measurement and an electrocardiogram (heart tracing) on entry to the study.
All participants will then undergo a one hour ultrasound examination of the neck, comprising thirty minutes lying flat and thirty minutes sitting upright.
At the end of the examination the images will be stored for future analysis at a another time point, i.e. results will not be disclosed to the participant.
Any willing participants will be invited back for a future rescan in 2 weeks by one of the same sonographers. No further follow up is required for this study.
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Primary outcome measure(s)
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1. Reflux (>0.88s) in the internal jugular (IJV) and vertebral veins (VVs) using triplex mode
2. High resolution B-mode evidence of IJV stenosis in transverse orientation (>50% cross-sectional area diameter reduction) with and without Valsalva
3. Undetectable Doppler flow in the IJVs and VVs using colour and Spectral Doppler
4. Cross-sectional area change of the IJV from the supine to sitting position
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Secondary outcome measure(s)
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Inter and intra sonographer reproducibility
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Sources of funding
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1. The Royal College of Surgeons of England (UK)
2. The Venous Forum at the Royal Society of Medicine (UK)
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Trial website
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Publications
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Contact name
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Dr
Richard
Nicholas
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Address
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MS Day Unit
4 North
Charing Cross Hospital
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City/town
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London
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Zip/Postcode
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W6 8RF
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Country
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United Kingdom
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Sponsor
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Imperial College London (UK)
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Address
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Joint Research Office
Exhibition Road
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City/town
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London
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Zip/Postcode
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SW7 2AZ
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Country
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United Kingdom
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Date applied
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17/10/2011
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Last edited
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14/11/2011
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Date ISRCTN assigned
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14/11/2011
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