Observational Study of the Prevalence of CCSVI in Multiple Sclerosis and in Other Neurodegenerative Diseases (COSMO)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Opera Srl
Information provided by (Responsible Party):
Fondazione Italiana Sclerosi Multipla
ClinicalTrials.gov Identifier:
NCT01384825
First received: June 27, 2011
Last updated: September 14, 2012
Last verified: September 2012
  Purpose

The presence of abnormalities in the cerebral venous circulation, defined as Chronic Cerebrospinal Venous Insufficiency (CCSVI), has recently been reported in patients with Multiple Sclerosis (MS), in healthy subjects and in subjects with other neurological diseases. These reports have aroused much interest both in the scientific world and, above all, among the communities of patients and Associations having the aim of aiding people with MS and of promoting scientific research into this disease.

In the literature published so far there is a lack of verification in large samples of the prevalence of CCSVI in MS compared with that observed in healthy subjects and in those with other diseases of the nervous system.

This is an observational study investigating the prevalence of CCSVI in subjects with MS and comparing it with the prevalence observed in a control population consisting of Healthy Controls (HC) and in a population affected by other neurological diseases of the central nervous system of degenerative, vascular, inflammatory and autoimmune origin.

A total of at least 1,200 adults with MS will be included in the study, as well as 400 healthy subjects and 400 subjects with other neurodegenerative diseases.


Condition
Multiple Sclerosis
Neurodegenerative Diseases

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Observational Study of the Prevalence of CCSVI in Multiple Sclerosis and in Other Neurodegenerative Diseases

Resource links provided by NLM:


Further study details as provided by Fondazione Italiana Sclerosi Multipla:

Primary Outcome Measures:
  • Prevalence of CCSVI [ Time Frame: The primary outcome will be assessed at enrollment (day 1). No follow-up is planned. ] [ Designated as safety issue: No ]
    The prevalence of CCSVI in MS (overall and in its various different forms) will be estimated, with 95% confidence intervals, and compared with that of the other groups. The differences in the prevalence of CCSVI between the various groups will be evaluated using the chi-square test. The sensitivity, specificity and accuracy of the method will be estimated with their 95% confidence intervals. Values of p equal to or lower than 0.05 will be considered significant.


Estimated Enrollment: 2000
Study Start Date: December 2010
Estimated Study Completion Date: October 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
MS
Subjects with Multiple Sclerosis
HC
Healthy Controls
OND
Subjects with Other Neurodegenerative Diseases, including both other non-inflammatory neurodegenerative diseases ("OND") and other inflammatory neurodegenerative diseases ("ONDi")

Detailed Description:

It has been recently reported the possible presence of abnormalities in the cerebral venous circulation of people with MS, in healthy controls and in people with other neurological diseases. These reports have aroused much interest both in the scientific world and, above all, among the communities of patients and Associations having the aim of aiding people with MS and of promoting scientific research into this disease. In particular, the studies by Zamboni and colleagues (Ferrara University) and by Zivadinov and colleagues (University of Buffalo) have suggested an association between CCSVI and MS that was widely reported by the mass media world-wide.

It can be noted that in the literature published so far there is a lack of verification in large samples of the prevalence of CCSVI in MS compared with that observed in healthy subjects and in those with other diseases of the nervous system. The recent and authoritative contributions from the scientific community involved with MS stressing the need for closely controlled and suitably designed clinical studies for investigating the hypotheses suggested with regard to CCSVI (with the necessary thoroughness and with the promptness demanded by the public opinion) are therefore definitely justified.

The possibility that there may be a new pathogenic mechanism underlying the development of MS, not in line with the majority of the experimental data concerning the aetiopathogenesis of this disease, has produced a strong echo throughout the scientific community. Increasingly, in recent months, both the working groups mentioned above and new authors have developed further research studies in order to confirm and extend the results obtained and to lay scientifically sound foundations for possible therapeutic applications for this discovery.

The Fondazione Italiana Sclerosi Multipla (FISM) Onlus, in its capacity as Promoter of this study, wishes, responsibly, to produce the best possible answer for people with MS all over the world. It therefore feels that it is necessary to proceed with the utmost scientific thoroughness, initially by means of a large-scale sample study for evaluating the prevalence of venous abnormalities in MS compared with that observed in normal controls and in controls with other diseases of the nervous system. In this context, the features of this study that distinguish it from previous studies and from the current state of knowledge are the following:

  1. Blind multi-Site observational study using the Echo-Color-Doppler equipment assigned to the study;
  2. Size of the sample with MS, of at least 1200 study subjects;
  3. Evaluation of the prevalence of CCSVI and of other malformations of the venous haemodynamics in the Clinically Isolated Syndrome (CIS), Relapsing-Remitting (RR), Primary Progressive (PP) and Secondary Progressive (SP) forms of MS, using a larger sample than those involved up to the present time.

In this observational study, the prevalence of CCSVI and of other malformations of the venous haemodynamics will be evaluated in different forms of MS and in other diseases of the nervous system. This is therefore an observational study investigating the prevalence of CCSVI in subjects with MS and comparing it with the prevalence observed in a control population consisting of healthy subjects and in a population of people with other neurological diseases of the central and peripheral nervous system of degenerative, vascular, inflammatory and autoimmune origin.

The study is a multi-Site observational study. A total of at least 1,200 adults with MS will be included in the study, as well as 400 healthy subjects and 400 subjects with other neurodegenerative diseases.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

A total of at least 1,200 adults with MS will be included in the study, as well as 400 healthy subjects and 400 subjects with other neurodegenerative diseases.

Criteria

Inclusion Criteria:

Group A (MS)

  • Age: 18 to 55;
  • Subjects of either sex with a diagnosis of MS according to McDonald's criteria and subsequent revisions (38, 39) and patients with CIS;
  • Course of the disease: RR - SP - PP - CIS;
  • Duration of the disease: from 1 month to 25 years for RR, SP and PP subjects; 5 years at most for the subjects with CIS,
  • Not in a period of clinical relapsing of the disease (at least 30 days since the last clinical relapse),
  • Subjects treated or not with immunomodulating and immunosuppressive drugs;
  • Signature of the informed consent form.

Group B (HC)

  • Age: 18 to 55;
  • No significant diseases and no familiarity for MS, that is to say healthy controls (HC);
  • Signature of the informed consent form. The subjects included in this group may be, for instance, non-blood relatives or spouses of the subjects with MS or with any of the other diseases being studied, or be linked to them by ties of affinity (e.g. a son-in-law with a father-in-law, a husband with his wife's brother, etc.) or accompanying persons or operators from other Sites.

Group C (OND)

  • Age: 18 to 55 ;
  • Subjects with other non-inflammatory neurodegenerative diseases (OND) such as, by way of example, Parkinson's disease, amyotrophic lateral sclerosis (ALS) and heredoataxia.
  • Signature of the informed consent form.

Group D (ONDi)

  • Age: 18 - 55
  • Patients with other inflammatory neurodegenerative diseases (ONDi) such as, by way of example, optical neuromyelitis (ONM), acute disseminated encephalomyelitis (ADEM), encephalitis, neurolupus, neurological complications of systemic autoimmune diseases.
  • Signature of the informed consent form.

Exclusion Criteria:

  • Presence of acute or chronic diseases of an invalidating nature or that could interfere with the design and aims of the study;
  • Clinically ascertained heart disease (New YOrk Heart AssoCiation (NYHA) Class ≥ I).
  • Past episodes of venous thromboembolism (including both Deep Vein Thrombosis and lung embolism).
  • Tumours.
  • Thrombophilia as defined in the case history.
  • Diabetes.
  • Primitive or secondary pulmonary hypertension and related treatment.
  • Concomitant systemic steroid treatment or in the last 30 days.
  • Current or past cerebrovascular disease.
  • Episodes of Transient Global Amnesia (TGA).
  • Obvious pregnancy.
  • Past diagnosis of CCSVI or earlier treatment for CCSVI.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01384825

Locations
Italy
Azienda Ospedali Riuniti - Div. di Neurologia - Centro Studi Sclerosi Multipla
Ancona, Italy, 60126
Università di Bari - Ospedale Consorziale Policlinico - Dip. Scienze Neurologiche e Psichiatriche
Bari, Italy, 70124
Azienda USL Città di Bologna - Distretto Santo Stefano Savena - Centro Sclerosi Multipla
Bologna, Italy, 40141
Azienda Ospedaliera Spedali Civili Presidio Montichiari - Centro Studi Sclerosi Multipla
Brescia, Italy, 25012
Università degli Studi di Cagliari - Centro Sclerosi Multipla - Ospedale Binaghi
Cagliari, Italy, 09126
Azienda Ospedaliera "Garibaldi" - U.O. Neurologia
Catania, Italy, 95122
Azienda Ospedaliera Universitaria "Policlinico Vittorio Emanuele" - Istituto Scienze Neurologiche
Catania, Italy, 95123
Istituto San Raffaele Giuseppe Giglio - Centro Sclerosi Multipla
Cefalù, Italy, 90015
Ospedale Universitario G. D'Annunzio - Centro Sclerosi Multipla
Chieti, Italy, 66013
Azienda Ospedaliera San Giuseppe - Centro Scl. Multipla - U.O. Neurologia
Empoli, Italy, 50053
Università degli Studi di Ferrara Arcispedale Sant'Anna - Istituto di Clinica Neurologica
Ferrara, Italy, 44100
Università degli Studi di Ferrara Arcispedale Sant'Anna - Clinica Neurologica
Ferrara, Italy, 44100
Azienda Ospedaliero Universitaria Careggi - Centro di Riferimento Regionale per la Sclerosi Multipla
Firenze, Italy, 50134
Azienda Ospedaliero Universitaria Careggi - Centro Sclerosi Multipla
Firenze, Italy, 50134
Azienda Ospedaliera Universitaria Ospedali Riuniti - Centro Sclerosi Multipla
Foggia, Italy, 71122
Ospedale S. Antonio Abate - Centro Studi Sclerosi Multipla
Gallarate, Italy, 21013
Azienda Ospedaliera Universitaria San Martino
Genova, Italy, 16132
Ospedale S. Andrea - Divisione di Neurologia
La Spezia, Italy, 19124
Ospedale Tappeiner - Div. Neurologica
Merano, Italy, 39012
IRCCS Centro Studi Neurolesi "Bonino Pulejo" di Messina
Messina, Italy, 98121
Azienda Ospedaliera Universitaria "G. Martino" - Dipartimento Neuroscienze Psichiatria e Anestesiologia
Messina, Italy, 98125
Università degli Studi di Milano - Dipartimento di Neurologia - Ospedale S. Raffaele - Via Olgettina , 60
Milano, Italy, 20132
Fondazione Ist. Neurologico Besta - Centro Sclerosi Multipla
Milano, Italy, 20133
Ospedale Niguarda Cà Granda - Centro Sclerosi Multipla
Milano, Italy, 20162
Fondazione Don Carlo Gnocchi, IRCCS Santa Maria Nascente - Unità Operativa Sclerosi Multipla
Milano, Italy, 20148
Università Federico II - Clinica Neurologica II
Napoli, Italy, 80131
Azienda Ospedaliera S. Luigi - Centro Sclerosi Multipla - Divisione Universitaria di Neurologia
Orbassano, Italy, 10043
Policlinico Az. Ospedaliera - Clinica Neurologica I
Padova, Italy, 35128
Università degli Studi di Palermo - Istituto di Neuropsichiatria - A.O.U.P. "P. Giaccone"
Palermo, Italy, 90129
Azienda Ospedaliera Villa Sofia C.T.O. - Neurologia Padiglione Geriatrico
Palermo, Italy, 90146
Istituto Neurologico C. Mondino - Divisione di Neurologia
Pavia, Italy, 27100
Arciospedale S. Maria Nuova - Centro Studi Sclerosi Multipla
Reggio Emilia, Italy, 42100
Ospedale Sant'Andrea - Neurologia e Centro Neurologico Terapie Sperimentali
Roma, Italy, 00189
Università Tor Vergata - Clinica Neurologica - Dipartimento di Neuroscienze
Roma, Italy, 00133
Università di Sassari - Clinica Neurologica
Sassari, Italy, 07100
Università degli Studi di Siena - Dip. di Neuroscienze - Sez. Neurologia
Siena, Italy, 53100
Università degli Studi di Siena - Dip. di Neuroscienze - U.O. Neurologia e Malattie Neurometaboliche
Siena, Italy, 53100
Azienda Ospedaliera Universitaria S. Giovanni Battista - Centro Sclerosi Multipla - Dipartimento di Neuroscienze
Torino, Italy, 10126
Azienda Ospedaliera "Ca Foncello" - Dipartimento di Neuroscienze - U.O. Neurologia
Treviso, Italy, 31100
Ospedale di Cattinara - Istituto Clinica Neurologica
Trieste, Italy, 34149
Ospedale S. Bortolo - Divisione di Neurologia - Centro Sclerosi Multipla
Vicenza, Italy, 36100
Azienda Sanitaria Provinciale di Ragusa Ospedale "R. Guzzardi" - U.O.C. Neurologia e Neurofisiopatologia, Stroke Unit
Vittoria, Italy, 97019
Sponsors and Collaborators
Fondazione Italiana Sclerosi Multipla
Opera Srl
Investigators
Principal Investigator: Giovanni L Mancardi, MD Università di Genova - Dipartimento di Neuroscienze, Oftalmologia e Genetica - Via De Toni, 5 - Genova
Principal Investigator: Giancarlo Comi Divisione di Neurologia e Servizio di Neurofisiologia, Ospedale San Raffaele di Milano
  More Information

No publications provided

Responsible Party: Fondazione Italiana Sclerosi Multipla
ClinicalTrials.gov Identifier: NCT01384825     History of Changes
Other Study ID Numbers: FISM 2010R1
Study First Received: June 27, 2011
Last Updated: September 14, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Fondazione Italiana Sclerosi Multipla:
Multiple Sclerosis
Other Neurodegenerative Diseases
Chronic CerebroSpinal Venous Insufficiency
Prevalence
Case-control

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Neurodegenerative Diseases
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014