Centralized Reading Assessment of Chronic CerebroSpinal Venous Insufficiency (CCSVI) in Patients With Multiple Sclerosis and Other Neurological Diseases
NCT ID: NCT02308579
Last Updated: 2016-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
499 participants
OBSERVATIONAL
2014-07-31
2015-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Multiple Sclerosis
Patients diagnosed with Multiple Sclerosis (MS), identified in the CTEVD trial
No interventions assigned to this group
Clinically Isolated Syndrome
Patients diagnosed with Clinically Isolated Syndrome (CIS), identified in the CTEVD trial.
No interventions assigned to this group
Other Neurological Disorders
Patients diagnosed with Other Neurological Disorders (OND), identified in the CTEVD trial. ONDs fall into one of four categories: Neurodegenerative, Vascular, Autoimmune, and Neuromuscular; and the following disorders: Acute Disseminated Encephalomyelitis (ADEM); Antiphospholipid Antibody (syndrome; APLA); Atypical, short-lasting neurodegenerative disease; Autoimmune disease not otherwise specified (NOS); Cerebellum Syndrome; Charcot-Marie Tooth Disease; Chiari Malformation; Chronic Fatigue Syndrome; Central Nervous System Vasculitis; Demyelinating Disease; Epilepsy; Headaches; Idiopathic Chronic Neuropathy; Migraines; Mitochondrial Disease; Myelopathy; Neurofibromatosis; Neuropathy; Optic Neuritis; Parasthesia related to Transient Ischemic Attacks (TIA); Parkinson's Disease; Restless legs syndrome; Seizures; Spinal Cerebellum Disease; Spinal Disc Degeneration; Syringomyelia; and Vertigo
No interventions assigned to this group
Healthy Controls
Individuals who are healthy (i.e., free from neurological conditions; HC) , identified in the CTEVD trial.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Available CDUS exam
* Diagnosed with CIS, MS, OND, or being a HC
Exclusion Criteria
* Diagnosed with Radiologically Isolated Syndrome (RIS) or Neuromyelitis Optic (NMO)
5 Years
80 Years
ALL
No
Sponsors
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University of Pavia
OTHER
University at Buffalo
OTHER
Responsible Party
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Robert Zivadinov, MD, PhD
Professor of Neurology
Principal Investigators
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Robert Zivadinov, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University at Buffalo
Other Identifiers
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CDUS1
Identifier Type: -
Identifier Source: org_study_id
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