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CompletedNCT01425554Updated Feb 10, 2015

Doppler Sonography, MR Venography, Plethysmography for the Diagnosis of CCSVI

An interventional study of Doppler sonography of internal jugular veins and Magnetic resonance venography of internal jugular veins in Chronic Cerebrospinal Venous Insufficiency, sponsored by Euromedic Specialist Clinics, Poland. Completed at 1 site in Poland. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-02-10.

Sponsored by Euromedic Specialist Clinics, Poland · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
126
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

This study is aimed at evaluation of diagnostic value of Doppler sonography, MR venography and air-plethysmography for the assessment of abnormalities in the internal jugular veins, with catheter venography as the reference test.

02

Conditions studied

  • Chronic Cerebrospinal Venous Insufficiency

Keywords

  • Vascular malformations in the internal jugular veins
03

In context

Lead sponsor

Euromedic Specialist Clinics, Poland is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

  1. Patients group

    Inclusion Criteria:

    • confirmed diagnosis of multiple sclerosis

    Exclusion Criteria:

    • coexisting another neurologic pathology (e.g. stroke, Parkinson disease)
    • significant stenosis of carotid or vertebral arteries
    • other significant abnormalities of blood vessels of the upper part of the body
    • tricuspid valve incompetence
    • allergy to iodine contrast dye
    • chronic renal failure
    • pregnancy
    • other severe comorbidities or significant abnormalities in standard lab tests
  2. Healthy volunteers.

Inclusion Criteria:

  • none

Exclusion Criteria:

  • confirmed diagnosis of multiple sclerosis or related pathologies (CIS, NMO)
  • coexisting another neurologic pathology (e.g. stroke, Parkinson disease)
  • significant stenosis of carotid or vertebral arteries
  • other significant abnormalities of blood vessels of the upper part of the body
  • tricuspid valve incompetence
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
126 participants (actual)

Study arms

  • No intervention
    Diagnostic study

    Other: Doppler sonography of internal jugular veins · Other: Magnetic resonance venography of internal jugular veins · Other: Air-plethysmography of the neck · Other: Catheter venography of internal jugular veins

Interventions

  • OtherDoppler sonography of internal jugular veins

    Doppler sonography of internal jugular veins

  • OtherMagnetic resonance venography of internal jugular veins

    Magnetic resonance venography of internal jugular veins

  • OtherAir-plethysmography of the neck

    Air-plethysmography of the neck

  • OtherCatheter venography of internal jugular veins

    Catheter venography of internal jugular veins

06

What researchers measure

Primary outcomes

  1. Positive and negative predictive value of Doppler sonography, MR venography and air-plethysmography

    Positive and negative predictive value of Doppler sonography,MR venography and air-plethysmography for the detecting of vascular malformation in the internal jugular veins with catheter venography as the reference test

    Time frame: All non-invasive test are done up to 14 days prior to catheter venography

07

Study locations

1 site
  • Euromedic Specialis Clinics; ul. Rolna 18
    Katowice, 40-555, Poland
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2011, a primary completion of Dec 2013 and a completion of Dec 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 28, 2011
First posted
Aug 30, 2011
Start
Aug 2011
Primary completionActual
Dec 2013
CompletionActual
Dec 2013
Last update
Feb 10, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 10, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01425554
Lead sponsor
Euromedic Specialist Clinics, Poland
Responsible party
Marian Simka (senior consultant, Euromedic Specialist Clinics, Poland) — Principal investigator
First posted
Aug 30, 2011
Start date
Aug 2011
Primary completion
Dec 2013
Completion
Dec 2013
Last update
Feb 10, 2015

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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