Centralized Reading Assessment of Chronic CerebroSpinal Venous Insufficiency (CCSVI) in Patients With Multiple Sclerosis and Other Neurological Diseases

This a retrospective, blinded trial in which collaborators in Italy will review the doppler findings from the Combined Transcranial and Extracranial Venous Doppler (CTEVD) trial in an attempt to measure reproducibility.

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Key information

Conditions

Clinically Isolated Syndrome (CIS) Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Healthy (HC) Immune System Diseases Multiple Sclerosis Multiple Sclerosis (MS) Nervous System Diseases Other Neurological Disorders (OND)

Age range

5 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

This study will retrospectively investigate doppler images from the second phase of the CTEVD trial.

To determine the prevalence of CCSVI in patients with MS, compared with the prevalence observed in a control population consisting of Other Neurological Diseases (OND) patients and Healthy Controls (HC) by using blinded, controlled centralized ultrasound reading assessment of 5 Venous Haemodynamic (VH) CCSVI CCSVI Doppler UltraSound (CDUS) criteria.
To investigate whether prevalence of CCSVI is different between centralized and local CDUS reading of 5 VH CCSVI CDUS criteria.
To investigate the prevalence of CCSVI in patients with MS, compared with the prevalence observed in a control population consisting of OND patients and HC, when bidirectional flow in the intracranial veins and sinuses CDUS criterion is not considered as part of VH CCSVI CDUS criteria.
To determine whether prevalence of CCSVI in patients with MS, compared with the prevalence observed in a control population consisting of OND patients and HC differs when using CDUS velocity and flow parameters in the Internal Jugular Veins (IJVs) and Vertebral Veins (VVs).
To determine the reproducibility of VH criteria by using of centralized and local blinded, controlled CDUS reading assessment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participation in the CTEVD Phase 2 study
Available CDUS exam
Diagnosed with CIS, MS, OND, or being a HC
Fulfilling inclusion criteria from the CTEVD study

Exclusion criteria

Not having an available CDUS exam
Diagnosed with Radiologically Isolated Syndrome (RIS) or Neuromyelitis Optic (NMO)
Fulfilling exclusion criteria from the CTEVD study

Treatment and study plan

Primary outcomes

Number of MS (or CIS) and HC (or OND) who have 5 VH CCSVI CDUS criteria on doppler ultrasound

Time frame: Baseline

The prevalence (number) of MS/CIS vs. HC/OND who fulfill the 5 venous haemodynamic (VH) criteria on doppler ultrasound.

Sponsors and collaborators

Lead sponsor

University at Buffalo

Other

Collaborators

University of Pavia

Registry information

Official study title

Prevalence of Chronic Cerebrospinal Venous Insufficiency in Patients With Multiple Sclerosis and Other Neurological Diseases. An Ultrasound, Blinded, Case-Controlled, Centralized Reading Assessment

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Dec 4, 2014
Registry last updated: Feb 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed