Trial record 9 of 13 for:    Ccsvi

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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 30, 2014