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

Chronic Cerebrospinal Venous Insufficiency Clinical Trial

Official title:

Doppler Sonography, Magnetic Resonance Venography, Air-plethysmography in the Non-invasive Diagnostics of Chronic Cerebrospinal Venous Insufficiency (CCSVI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01425554
• Other study ID #: 20/2011
• Status: Completed
• Phase: N/A
• First received: August 28, 2011
• Last updated: February 9, 2015
• Start date: August 2011
• Est. completion date: December 2013

Study information

• Verified date: February 2015
• Source: Euromedic Specialist Clinics, Poland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: The Central Register of Clinical Trials
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chronic Cerebrospinal Venous Insufficiency
• Venous Insufficiency

Intervention

Other:
• Doppler sonography of internal jugular veins
Doppler sonography of internal jugular veins
• Magnetic resonance venography of internal jugular veins
Magnetic resonance venography of internal jugular veins
• Air-plethysmography of the neck
Air-plethysmography of the neck
• Catheter venography of internal jugular veins
Catheter venography of internal jugular veins

Locations

Country	Name	City	State
Poland	Euromedic Specialis Clinics; ul. Rolna 18	Katowice

Sponsors (1)

Lead Sponsor	Collaborator
Euromedic Specialist Clinics, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive and negative predictive value of Doppler sonography, MR venography and air-plethysmography	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	All non-invasive test are done up to 14 days prior to catheter venography	No