Clinically Isolated Syndrome (CIS)NCT02308579
Centralized Reading Assessment of Chronic CerebroSpinal Venous Insufficiency (CCSVI) in Patients With Multiple Sclerosis and Other Neurological Diseases
An observational study of Clinically Isolated Syndrome (CIS) and Multiple Sclerosis (MS), run by University at Buffalo.
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. Read more about this study
- Who is it for?
- Ages 5 to 80 years
- Conditions the study is for
- Clinically Isolated Syndrome (CIS), Multiple Sclerosis (MS), Other Neurological Disorders (OND)
- How many people
- 499 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Not having an available CDUS exam
- Diagnosed with Radiologically Isolated Syndrome (RIS) or Neuromyelitis Optic (NMO)
- Fulfilling exclusion criteria from the CTEVD study
About this study
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
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.
Read the detailed description
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.
- Conditions
- Clinically Isolated Syndrome (CIS), Multiple Sclerosis (MS), Other Neurological Disorders (OND), Healthy (HC)
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Multiple Sclerosis | 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 | |
| Healthy Controls | Individuals who are healthy (i.e., free from neurological conditions; HC) , identified in the CTEVD trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startJul 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinically Isolated Syndrome (CIS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 499 participants (actual)
Sponsor and investigators
- Lead sponsor
- University at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pavia
- Responsible party
- Principal investigator, Robert Zivadinov, MD, PhD, University at Buffalo
- Investigators
- Robert Zivadinov, MD, PhD, Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02308579
- Sponsor's protocol ID
- CDUS1
- Status last verified
- Feb 2016
- First submitted
- 8 Jul 2014
- Last updated
- 12 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02308579
- Acronym / sponsor ID
- CDUS1
- Conditions
- Clinically Isolated Syndrome (CIS), Multiple Sclerosis (MS), Other Neurological Disorders (OND), Healthy (HC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 499 participants (actual)
- Lead sponsor
- University at BuffaloUniversity, hospital or other
- Collaborators
- University of Pavia
- Study start
- Jul 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 4 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Multiple Sclerosis | – | –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 |
| Healthy Controls | – | –Individuals who are healthy (i.e., free from neurological conditions; HC) , identified in the CTEVD trial. |
Who may qualify
- Ages
- 5 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Not having an available CDUS exam
- Diagnosed with Radiologically Isolated Syndrome (RIS) or Neuromyelitis Optic (NMO)
- Fulfilling exclusion criteria from the CTEVD study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2016.
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RecruitingObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Zivadinov, MD, PhD principal investigator
University at Buffalo
Questions about this trial
What is this clinical trial studying?
An observational study of Clinically Isolated Syndrome (CIS) and Multiple Sclerosis (MS), run by University at Buffalo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of MS (or CIS) and HC (or OND) who have 5 VH CCSVI CDUS criteria on doppler ultrasound (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2016.