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

Primary Purpose

Chronic Cerebrospinal Venous Insufficiency

Status

Completed

Phase

Not Applicable

Locations

Poland

Study Type

Interventional

Intervention

Doppler sonography of internal jugular veins

Magnetic resonance venography of internal jugular veins

Air-plethysmography of the neck

Catheter venography of internal jugular veins

About this trial

This is an interventional diagnostic trial for Chronic Cerebrospinal Venous Insufficiency focused on measuring Vascular malformations in the internal jugular veins

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Euromedic Specialis Clinics; ul. Rolna 18

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

Diagnostic study

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01425554

First Posted

August 28, 2011

Last Updated

February 9, 2015

Sponsor

Euromedic Specialist Clinics, Poland

1. Study Identification

Unique Protocol Identification Number

NCT01425554

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Completed

Study Start Date

August 2011 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Euromedic Specialist Clinics, Poland

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Cerebrospinal Venous Insufficiency

Keywords

Vascular malformations in the internal jugular veins

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

126 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Diagnostic study

Arm Type

No Intervention

Intervention Type

Other

Intervention Name(s)

Doppler sonography of internal jugular veins

Intervention Description

Doppler sonography of internal jugular veins

Intervention Type

Other

Intervention Name(s)

Magnetic resonance venography of internal jugular veins

Intervention Description

Magnetic resonance venography of internal jugular veins

Intervention Type

Other

Intervention Name(s)

Air-plethysmography of the neck

Intervention Description

Air-plethysmography of the neck

Intervention Type

Other

Intervention Name(s)

Catheter venography of internal jugular veins

Intervention Description

Catheter venography of internal jugular veins

Primary Outcome Measure Information:

Title

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

Description

Time Frame

All non-invasive test are done up to 14 days prior to catheter venography

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Euromedic Specialis Clinics; ul. Rolna 18

City

Katowice

ZIP/Postal Code

40-555

Country

Poland

12. IPD Sharing Statement

Learn more about this trial

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

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