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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Marian Simka, Euromedic Specialist Clinics, Poland
ClinicalTrials.gov Identifier:
NCT01425554
First received: August 28, 2011
Last updated: January 30, 2013
Last verified: January 2013

August 28, 2011
January 30, 2013
August 2011
December 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01425554 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Doppler Sonography, MR Venography, Plethysmography for the Diagnosis of CCSVI
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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Chronic Cerebrospinal Venous Insufficiency
  • 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
No Intervention: Diagnostic study
Interventions:
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
December 2013
December 2013   (final data collection date for primary outcome measure)
  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
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT01425554
20/2011
Yes
Marian Simka, Euromedic Specialist Clinics, Poland
Euromedic Specialist Clinics, Poland
Not Provided
Not Provided
Euromedic Specialist Clinics, Poland
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP