Observational case-control study of the prevalence of chronic cerebrospinal venous insufficiency in multiple sclerosis: Results from the CoSMo study

G. Comi, M. A. Battaglia, A. Bertolotto, M. Del Sette, A. Ghezzi, G. Malferrari, M. Salvetti, M. P. Sormani, L. Tesio, E. Stolz, P. Zaratin, G. Mancardi

Research output: Contribution to journalArticle

34 Citations (Scopus)

Abstract

Background: Chronic cerebrospinal venous insufficiency (CCSVI) has been proposed as a possible cause of multiple sclerosis (MS). Objectives: The CoSMo study evaluated the association between CCSVI and MS. Methods: The primary end-point of this multicentric, case-control study was to compare the prevalence of CCSVI between patients with MS, patients with other neurodegenerative diseases (ONDs) and healthy controls (HCs). Color-coded duplex sonography was performed by a sonologist and the images were sent to one of three central sonologists for a second reading. Agreement between local and central sonologists or, in case of disagreement, the predominant judgment among the three central readers, was required for a diagnosis of CCSVI. All readings, data collection and analysis were blinded. Results: The study involved 35 MS centers across Italy and included 1874 subjects aged 18-55. 1767 (94%) were evaluable: 1165 MS patients, 226 patients with ONDs and 376 HCs. CCSVI prevalence was 3.26%, 3.10% and 2.13% for the MS, OND and HC groups, respectively. No significant difference in CCSVI prevalence was found amongst the three cohorts (MS versus HC, OR = 1.55, 95%CI = 0.72-3.36, ρ= 0.30; OND versus HC, OR = 1.47, 95%CI = 0.53-4.11, ρ= 0.46; MS versus OND, OR = 1.05, 95%CI = 0.47-2.39, ρ = 0.99). High negative and low positive agreement was found between the local and centralized readers. Conclusions: CCSVI is not associated with MS.

Original languageEnglish
Pages (from-to)1508-1517
Number of pages10
JournalMultiple Sclerosis Journal
Volume19
Issue number11
DOIs
Publication statusPublished - 2013

Fingerprint

Venous Insufficiency
Multiple Sclerosis
Case-Control Studies
Neurodegenerative Diseases
Reading
Italy
Ultrasonography
Color
Control Groups

Keywords

  • Chronic cerebrospinal venous insufficiency
  • circulatory system
  • Italy
  • multicentric study
  • multiple sclerosis
  • neurodegenerative disease
  • prevalence study
  • sonography

ASJC Scopus subject areas

  • Clinical Neurology
  • Neurology

Cite this

Observational case-control study of the prevalence of chronic cerebrospinal venous insufficiency in multiple sclerosis : Results from the CoSMo study. / Comi, G.; Battaglia, M. A.; Bertolotto, A.; Sette, M. Del; Ghezzi, A.; Malferrari, G.; Salvetti, M.; Sormani, M. P.; Tesio, L.; Stolz, E.; Zaratin, P.; Mancardi, G.

In: Multiple Sclerosis Journal, Vol. 19, No. 11, 2013, p. 1508-1517.

Research output: Contribution to journalArticle

Comi, G, Battaglia, MA, Bertolotto, A, Sette, MD, Ghezzi, A, Malferrari, G, Salvetti, M, Sormani, MP, Tesio, L, Stolz, E, Zaratin, P & Mancardi, G 2013, 'Observational case-control study of the prevalence of chronic cerebrospinal venous insufficiency in multiple sclerosis: Results from the CoSMo study', Multiple Sclerosis Journal, vol. 19, no. 11, pp. 1508-1517. https://doi.org/10.1177/1352458513501231
Comi, G. ; Battaglia, M. A. ; Bertolotto, A. ; Sette, M. Del ; Ghezzi, A. ; Malferrari, G. ; Salvetti, M. ; Sormani, M. P. ; Tesio, L. ; Stolz, E. ; Zaratin, P. ; Mancardi, G. / Observational case-control study of the prevalence of chronic cerebrospinal venous insufficiency in multiple sclerosis : Results from the CoSMo study. In: Multiple Sclerosis Journal. 2013 ; Vol. 19, No. 11. pp. 1508-1517.
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title = "Observational case-control study of the prevalence of chronic cerebrospinal venous insufficiency in multiple sclerosis: Results from the CoSMo study",
abstract = "Background: Chronic cerebrospinal venous insufficiency (CCSVI) has been proposed as a possible cause of multiple sclerosis (MS). Objectives: The CoSMo study evaluated the association between CCSVI and MS. Methods: The primary end-point of this multicentric, case-control study was to compare the prevalence of CCSVI between patients with MS, patients with other neurodegenerative diseases (ONDs) and healthy controls (HCs). Color-coded duplex sonography was performed by a sonologist and the images were sent to one of three central sonologists for a second reading. Agreement between local and central sonologists or, in case of disagreement, the predominant judgment among the three central readers, was required for a diagnosis of CCSVI. All readings, data collection and analysis were blinded. Results: The study involved 35 MS centers across Italy and included 1874 subjects aged 18-55. 1767 (94{\%}) were evaluable: 1165 MS patients, 226 patients with ONDs and 376 HCs. CCSVI prevalence was 3.26{\%}, 3.10{\%} and 2.13{\%} for the MS, OND and HC groups, respectively. No significant difference in CCSVI prevalence was found amongst the three cohorts (MS versus HC, OR = 1.55, 95{\%}CI = 0.72-3.36, ρ= 0.30; OND versus HC, OR = 1.47, 95{\%}CI = 0.53-4.11, ρ= 0.46; MS versus OND, OR = 1.05, 95{\%}CI = 0.47-2.39, ρ = 0.99). High negative and low positive agreement was found between the local and centralized readers. Conclusions: CCSVI is not associated with MS.",
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T1 - Observational case-control study of the prevalence of chronic cerebrospinal venous insufficiency in multiple sclerosis

T2 - Results from the CoSMo study

AU - Comi, G.

AU - Battaglia, M. A.

AU - Bertolotto, A.

AU - Sette, M. Del

AU - Ghezzi, A.

AU - Malferrari, G.

AU - Salvetti, M.

AU - Sormani, M. P.

AU - Tesio, L.

AU - Stolz, E.

AU - Zaratin, P.

AU - Mancardi, G.

PY - 2013

Y1 - 2013

N2 - Background: Chronic cerebrospinal venous insufficiency (CCSVI) has been proposed as a possible cause of multiple sclerosis (MS). Objectives: The CoSMo study evaluated the association between CCSVI and MS. Methods: The primary end-point of this multicentric, case-control study was to compare the prevalence of CCSVI between patients with MS, patients with other neurodegenerative diseases (ONDs) and healthy controls (HCs). Color-coded duplex sonography was performed by a sonologist and the images were sent to one of three central sonologists for a second reading. Agreement between local and central sonologists or, in case of disagreement, the predominant judgment among the three central readers, was required for a diagnosis of CCSVI. All readings, data collection and analysis were blinded. Results: The study involved 35 MS centers across Italy and included 1874 subjects aged 18-55. 1767 (94%) were evaluable: 1165 MS patients, 226 patients with ONDs and 376 HCs. CCSVI prevalence was 3.26%, 3.10% and 2.13% for the MS, OND and HC groups, respectively. No significant difference in CCSVI prevalence was found amongst the three cohorts (MS versus HC, OR = 1.55, 95%CI = 0.72-3.36, ρ= 0.30; OND versus HC, OR = 1.47, 95%CI = 0.53-4.11, ρ= 0.46; MS versus OND, OR = 1.05, 95%CI = 0.47-2.39, ρ = 0.99). High negative and low positive agreement was found between the local and centralized readers. Conclusions: CCSVI is not associated with MS.

AB - Background: Chronic cerebrospinal venous insufficiency (CCSVI) has been proposed as a possible cause of multiple sclerosis (MS). Objectives: The CoSMo study evaluated the association between CCSVI and MS. Methods: The primary end-point of this multicentric, case-control study was to compare the prevalence of CCSVI between patients with MS, patients with other neurodegenerative diseases (ONDs) and healthy controls (HCs). Color-coded duplex sonography was performed by a sonologist and the images were sent to one of three central sonologists for a second reading. Agreement between local and central sonologists or, in case of disagreement, the predominant judgment among the three central readers, was required for a diagnosis of CCSVI. All readings, data collection and analysis were blinded. Results: The study involved 35 MS centers across Italy and included 1874 subjects aged 18-55. 1767 (94%) were evaluable: 1165 MS patients, 226 patients with ONDs and 376 HCs. CCSVI prevalence was 3.26%, 3.10% and 2.13% for the MS, OND and HC groups, respectively. No significant difference in CCSVI prevalence was found amongst the three cohorts (MS versus HC, OR = 1.55, 95%CI = 0.72-3.36, ρ= 0.30; OND versus HC, OR = 1.47, 95%CI = 0.53-4.11, ρ= 0.46; MS versus OND, OR = 1.05, 95%CI = 0.47-2.39, ρ = 0.99). High negative and low positive agreement was found between the local and centralized readers. Conclusions: CCSVI is not associated with MS.

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