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

Not Applicable

Completed

• Conditions: Chronic Cerebrospinal Venous Insufficiency
• 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

• Registration Number: NCT01425554
• Lead Sponsor: Euromedic Specialist Clinics, Poland

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-28
• Study First Submitted QC: 2011-08-29
• Study First Posted: 2011-08-30
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-09
• Last Update Posted: 2015-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic study	Air-plethysmography of the neck	-
Diagnostic study	Catheter venography of internal jugular veins	-
Diagnostic study	Doppler sonography of internal jugular veins	-
Diagnostic study	Magnetic resonance venography of internal jugular veins	-

Primary Outcome Measures

Name	Time	Method
Positive and negative predictive value of Doppler sonography, MR venography and air-plethysmography	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

Trial Locations

Locations (1)

Euromedic Specialis Clinics; ul. Rolna 18; 🇵🇱 Katowice, Poland