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

Completed

• Conditions: Healthy (HC); Clinically Isolated Syndrome (CIS); Multiple Sclerosis (MS); Other Neurological Disorders (OND)

• Registration Number: NCT02308579
• Lead Sponsor: University at Buffalo

Brief Summary

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.

Detailed Description

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

1. 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.

2. To investigate whether prevalence of CCSVI is different between centralized and local CDUS reading of 5 VH CCSVI CDUS criteria.

3. 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.

4. 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).

5. To determine the reproducibility of VH criteria by using of centralized and local blinded, controlled CDUS reading assessment.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-08
• Study First Submitted QC: 2014-12-02
• Study First Posted: 2014-12-04
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-11
• Last Update Posted: 2016-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 499

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of MS (or CIS) and HC (or OND) who have 5 VH CCSVI CDUS criteria on doppler ultrasound	Baseline	The prevalence (number) of MS/CIS vs. HC/OND who fulfill the 5 venous haemodynamic (VH) criteria on doppler ultrasound.