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

NCT01384825 | Completed DMC

• 1 other identifier: FISM 2010R1
• Study Type: observational
• Target: 200
• Locations: 2 countries
• Sites: 43

Brief Summary

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.

Conditions

Multiple Sclerosis; Neurodegenerative Diseases

Keywords

Multiple Sclerosis; Other Neurodegenerative Diseases; Chronic CerebroSpinal Venous Insufficiency; Prevalence; Case-control

Outcome Measures

Primary Outcomes (1)

• Prevalence of CCSVI

  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.

  The primary outcome will be assessed at enrollment (day 1). No follow-up is planned.

Study Arms (3)

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")

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Italiana Sclerosi Multipla: lead
• Opera CRO, a TIGERMED Group Company: collaborator

Study Sites (43)

Azienda Ospedali Riuniti - Div. di Neurologia - Centro Studi Sclerosi Multipla

Ancona, 60126, Italy

Location

Università di Bari - Ospedale Consorziale Policlinico - Dip. Scienze Neurologiche e Psichiatriche

Bari, 70124, Italy

Location

Azienda USL Città di Bologna - Distretto Santo Stefano Savena - Centro Sclerosi Multipla

Bologna, 40141, Italy

Location

Azienda Ospedaliera Spedali Civili Presidio Montichiari - Centro Studi Sclerosi Multipla

Brescia, 25012, Italy

Location

Università degli Studi di Cagliari - Centro Sclerosi Multipla - Ospedale Binaghi

Cagliari, 09126, Italy

Location

Azienda Ospedaliera "Garibaldi" - U.O. Neurologia

Catania, 95122, Italy

Location

Azienda Ospedaliera Universitaria "Policlinico Vittorio Emanuele" - Istituto Scienze Neurologiche

Catania, 95123, Italy

Location

Istituto San Raffaele Giuseppe Giglio - Centro Sclerosi Multipla

Cefalù, 90015, Italy

Location

Ospedale Universitario G. D'Annunzio - Centro Sclerosi Multipla

Chieti, 66013, Italy

Location

Azienda Ospedaliera San Giuseppe - Centro Scl. Multipla - U.O. Neurologia

Empoli, 50053, Italy

Location

Università degli Studi di Ferrara Arcispedale Sant'Anna - Clinica Neurologica

Ferrara, 44100, Italy

Location

Università degli Studi di Ferrara Arcispedale Sant'Anna - Istituto di Clinica Neurologica

Ferrara, 44100, Italy

Location

Azienda Ospedaliero Universitaria Careggi - Centro di Riferimento Regionale per la Sclerosi Multipla

Florence, 50134, Italy

Location

Azienda Ospedaliero Universitaria Careggi - Centro Sclerosi Multipla

Florence, 50134, Italy

Location

Azienda Ospedaliera Universitaria Ospedali Riuniti - Centro Sclerosi Multipla

Foggia, 71122, Italy

Location

Ospedale S. Antonio Abate - Centro Studi Sclerosi Multipla

Gallarate, 21013, Italy

Location

Azienda Ospedaliera Universitaria San Martino

Genova, 16132, Italy

Location

Ospedale S. Andrea - Divisione di Neurologia

La Spezia, 19124, Italy

Location

Ospedale Tappeiner - Div. Neurologica

Merano, 39012, Italy

Location

IRCCS Centro Studi Neurolesi "Bonino Pulejo" di Messina

Messina, 98121, Italy

Location

Azienda Ospedaliera Universitaria "G. Martino" - Dipartimento Neuroscienze Psichiatria e Anestesiologia

Messina, 98125, Italy

Location

Università degli Studi di Milano - Dipartimento di Neurologia - Ospedale S. Raffaele - Via Olgettina , 60

Milan, 20132, Italy

Location

Fondazione Ist. Neurologico Besta - Centro Sclerosi Multipla

Milan, 20133, Italy

Location

Fondazione Don Carlo Gnocchi, IRCCS Santa Maria Nascente - Unità Operativa Sclerosi Multipla

Milan, 20148, Italy

Location

Ospedale Niguarda Cà Granda - Centro Sclerosi Multipla

Milan, 20162, Italy

Location

Università Federico II - Clinica Neurologica II

Napoli, 80131, Italy

Location

Azienda Ospedaliera S. Luigi - Centro Sclerosi Multipla - Divisione Universitaria di Neurologia

Orbassano, 10043, Italy

Location

Policlinico Az. Ospedaliera - Clinica Neurologica I

Padua, 35128, Italy

Location

Università degli Studi di Palermo - Istituto di Neuropsichiatria - A.O.U.P. "P. Giaccone"

Palermo, 90129, Italy

Location

Azienda Ospedaliera Villa Sofia C.T.O. - Neurologia Padiglione Geriatrico

Palermo, 90146, Italy

Location

Istituto Neurologico C. Mondino - Divisione di Neurologia

Pavia, 27100, Italy

Location

Arciospedale S. Maria Nuova - Centro Studi Sclerosi Multipla

Reggio Emilia, 42100, Italy

Location

Università Tor Vergata - Clinica Neurologica - Dipartimento di Neuroscienze

Roma, 00133, Italy

Location

Ospedale Sant'Andrea - Neurologia e Centro Neurologico Terapie Sperimentali

Roma, 00189, Italy

Location

Università di Sassari - Clinica Neurologica

Sassari, 07100, Italy

Location

Università degli Studi di Siena - Dip. di Neuroscienze - Sez. Neurologia

Siena, 53100, Italy

Location

Università degli Studi di Siena - Dip. di Neuroscienze - U.O. Neurologia e Malattie Neurometaboliche

Siena, 53100, Italy

Location

Azienda Ospedaliera Universitaria S. Giovanni Battista - Centro Sclerosi Multipla - Dipartimento di Neuroscienze

Torino, 10126, Italy

Location

Azienda Ospedaliera "Ca Foncello" - Dipartimento di Neuroscienze - U.O. Neurologia

Treviso, 31100, Italy

Location

Ospedale di Cattinara - Istituto Clinica Neurologica

Trieste, 34149, Italy

Location

Ospedale S. Bortolo - Divisione di Neurologia - Centro Sclerosi Multipla

Vicenza, 36100, Italy

Location

Azienda Sanitaria Provinciale di Ragusa Ospedale "R. Guzzardi" - U.O.C. Neurologia e Neurofisiopatologia, Stroke Unit

Vittoria, 97019, Italy

Location

Opera Contract Research Organization SRL

Timișoara, Timiș County, 300209, Romania

Location

MeSH Terms

Conditions

Multiple Sclerosis; Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2011
• First Posted: June 29, 2011
• Study Start: December 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: October 1, 2012
• Last Updated: January 16, 2018

Record last verified: 2018-01

Locations

IT (42); RO (1)