Centralized Reading Assessment of Chronic CerebroSpinal Venous Insufficiency (CCSVI) in Patients With Multiple Sclerosis and Other Neurological Diseases
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|ClinicalTrials.gov Identifier: NCT02308579|
Recruitment Status : Completed
First Posted : December 4, 2014
Last Update Posted : February 12, 2016
|Condition or disease|
|Clinically Isolated Syndrome (CIS) Multiple Sclerosis (MS) Other Neurological Disorders (OND) Healthy (HC)|
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.
|Study Type :||Observational|
|Actual Enrollment :||499 participants|
|Observational Model:||Case Control|
|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 Start Date :||July 2014|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
Patients diagnosed with Multiple Sclerosis (MS), identified in the CTEVD trial
Clinically Isolated Syndrome
Patients diagnosed with Clinically Isolated Syndrome (CIS), identified in the CTEVD trial.
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
Individuals who are healthy (i.e., free from neurological conditions; HC) , identified in the CTEVD trial.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02308579
|Principal Investigator:||Robert Zivadinov, MD, PhD||University at Buffalo|