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

NCT ID: NCT01425554

Last Updated: 2015-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-12-31

Brief Summary

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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

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Conditions

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Chronic Cerebrospinal Venous Insufficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic study

Group Type NO_INTERVENTION

Doppler sonography of internal jugular veins

Intervention Type OTHER

Doppler sonography of internal jugular veins

Magnetic resonance venography of internal jugular veins

Intervention Type OTHER

Magnetic resonance venography of internal jugular veins

Air-plethysmography of the neck

Intervention Type OTHER

Air-plethysmography of the neck

Catheter venography of internal jugular veins

Intervention Type OTHER

Catheter venography of internal jugular veins

Interventions

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Doppler sonography of internal jugular veins

Doppler sonography of internal jugular veins

Intervention Type OTHER

Magnetic resonance venography of internal jugular veins

Magnetic resonance venography of internal jugular veins

Intervention Type OTHER

Air-plethysmography of the neck

Air-plethysmography of the neck

Intervention Type OTHER

Catheter venography of internal jugular veins

Catheter venography of internal jugular veins

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* confirmed diagnosis of multiple sclerosis


* none

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.


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Euromedic Specialist Clinics, Poland

OTHER

Sponsor Role lead

Responsible Party

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Marian Simka

senior consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Euromedic Specialis Clinics; ul. Rolna 18

Katowice, , Poland

Site Status

Countries

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Poland

Other Identifiers

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20/2011

Identifier Type: -

Identifier Source: org_study_id

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