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

Tracking Information
First Received Date ^ICMJE	August 28, 2011
Last Updated Date	January 30, 2013
Start Date ^ICMJE	August 2011
Estimated Primary Completion Date	December 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 29, 2011)	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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01425554 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Doppler Sonography, MR Venography, Plethysmography for the Diagnosis of CCSVI
Official Title ^ICMJE	Doppler Sonography, Magnetic Resonance Venography, Air-plethysmography in the Non-invasive Diagnostics of Chronic Cerebrospinal Venous Insufficiency (CCSVI)
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Condition ^ICMJE	Chronic Cerebrospinal Venous Insufficiency
Intervention ^ICMJE	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
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	200
Estimated Completion Date	December 2013
Estimated Primary Completion Date	December 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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 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
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Poland

Administrative Information
NCT Number ^ICMJE	NCT01425554
Other Study ID Numbers ^ICMJE	20/2011
Has Data Monitoring Committee	Yes
Responsible Party	Marian Simka, Euromedic Specialist Clinics, Poland
Study Sponsor ^ICMJE	Euromedic Specialist Clinics, Poland
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Euromedic Specialist Clinics, Poland
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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