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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01425554
First Posted: August 30, 2011
Last Update Posted: February 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Marian Simka, Euromedic Specialist Clinics, Poland
  Purpose
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.

Condition Intervention
Chronic Cerebrospinal Venous Insufficiency 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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Doppler Sonography, Magnetic Resonance Venography, Air-plethysmography in the Non-invasive Diagnostics of Chronic Cerebrospinal Venous Insufficiency (CCSVI)

Resource links provided by NLM:


Further study details as provided by Marian Simka, Euromedic Specialist Clinics, Poland:

Primary Outcome Measures:
  • 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


Enrollment: 126
Study Start Date: August 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

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
  Contacts and Locations
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): NCT01425554


Locations
Poland
Euromedic Specialis Clinics; ul. Rolna 18
Katowice, Poland, 40-555
Sponsors and Collaborators
Euromedic Specialist Clinics, Poland
  More Information

Responsible Party: Marian Simka, senior consultant, Euromedic Specialist Clinics, Poland
ClinicalTrials.gov Identifier: NCT01425554     History of Changes
Other Study ID Numbers: 20/2011
First Submitted: August 28, 2011
First Posted: August 30, 2011
Last Update Posted: February 10, 2015
Last Verified: February 2015

Keywords provided by Marian Simka, Euromedic Specialist Clinics, Poland:
Vascular malformations in the internal jugular veins

Additional relevant MeSH terms:
Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases