Clinical trial NCT02308579: Centralized Reading Assessment of Chronic CerebroSpinal Venous Insufficiency (CCSVI) in Patients With Multiple Sclerosis and Other Neurological Diseases
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clinically Isolated Syndrome (CIS)
Multiple Sclerosis (MS)
Other Neurological Disorders (OND)
Healthy (HC)
Lead sponsor: University at Buffalo
Sponsor class: OTHER
Collaborators: name: University of Pavia
First posted: 2014-12-04
Enrollment: 499
Sex: ALL
Minimum age (years): 5
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants in this study will be those who had participated in the second phase of the Combined Transcranial/Extracranial Venous Deficiency (CTEVD) study.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of MS (or CIS) and HC (or OND) who have 5 VH CCSVI CDUS criteria on doppler ultrasound
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University at Buffalo
name: Robert Zivadinov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: