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

Multiple Sclerosis (MS) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02308579
• Other study ID #: CDUS1
• Status: Completed
• Phase: N/A
• First received: July 8, 2014
• Last updated: February 11, 2016
• Start date: July 2014
• Est. completion date: March 2015

Study information

• Verified date: February 2016
• Source: University at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 499
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 80 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Clinically Isolated Syndrome (CIS)
• Healthy (HC)
• Multiple Sclerosis
• Multiple Sclerosis (MS)
• Nervous System Diseases
• Other Neurological Disorders (OND)
• Sclerosis
• Venous Insufficiency

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University at Buffalo	University of Pavia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of MS (or CIS) and HC (or OND) who have 5 VH CCSVI CDUS criteria on doppler ultrasound	The prevalence (number) of MS/CIS vs. HC/OND who fulfill the 5 venous haemodynamic (VH) criteria on doppler ultrasound.	Baseline	No