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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
History of Changes
  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: 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:

U.S. FDA Resources

Further study details as provided by 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 ] [ 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


Estimated Enrollment: 200
Study Start Date: August 2011
Estimated Study Completion Date: December 2013
Estimated 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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01425554

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

No publications provided

Responsible Party: Marian Simka, senior consultant, Euromedic Specialist Clinics, Poland
ClinicalTrials.gov Identifier: NCT01425554     History of Changes
Other Study ID Numbers: 20/2011
Study First Received: August 28, 2011
Last Updated: January 30, 2013
Health Authority: Poland: The Central Register of Clinical Trials

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

Additional relevant MeSH terms:
Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 17, 2013