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

February 9, 2015 updated by: Marian Simka, Euromedic Specialist Clinics, Poland

Doppler Sonography, Magnetic Resonance Venography, Air-plethysmography in the Non-invasive Diagnostics of Chronic Cerebrospinal Venous Insufficiency (CCSVI)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Diagnostic study
Other: Doppler sonography of internal jugular veins
Doppler sonography of internal jugular veins
Other: Magnetic resonance venography of internal jugular veins
Magnetic resonance venography of internal jugular veins
Other: Air-plethysmography of the neck
Air-plethysmography of the neck
Other: Catheter venography of internal jugular veins
Catheter venography of internal jugular veins

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive and negative predictive value of Doppler sonography, MR venography and air-plethysmography
Time Frame: All non-invasive test are done up to 14 days prior to catheter venography
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
All non-invasive test are done up to 14 days prior to catheter venography

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Euromedic Specialist Clinics, Poland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

August 28, 2011

First Submitted That Met QC Criteria

August 29, 2011

First Posted (Estimate)

August 30, 2011

Study Record Updates

Last Update Posted (Estimate)

February 10, 2015

Last Update Submitted That Met QC Criteria

February 9, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20/2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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