summary of CCSVI prevalence trials to date
Posted: Fri Aug 19, 2011 7:57 am
I have been doing a summary of the trials that have been published (only CCSVI in MS prevalence trials, trials about the effects of angioplasty are excluded)
Please, add any other trial not listed here (specially negative studies), to keep a track.
1- Intracranial Venous Haemodynamics in MS, 2007, performed by Zamboni's team. They took 89 MS patients and 60 controls looking for flood problems in MS .(Zamboni P, Menegatti E, Bartolomei I, et al. Intracranial venous haemodynamics in multiple sclerosis. Curr Neurovasc Res 2007;4(4):252-8). They identified five anomalous parameters of venous blood back into the brains of people with MS comparing 89 people with MS to 60 controls. They proposed a technique combining TCCS (transcranial color coded duplex sonography) and ECD (Echo color doppler) to meassure the backflows.
2 - Chronic cerebrospinal venous insufficiency in patients with multiple sclerosis (April 2008). Second trial of Zamboni and his third CCSVI related article. They presented 65 people with MS and compared them to 235 control patients, of whom 45 had other neurological diseases. They used five tests with the TCCS-ECD criteria they had devised. They coined the term chronic cerebro-spinal venous insufficiency (CCSVI) for the venous problems they reported (Zamboni P, Galeotti R, Menegatti E, et al. Chronic cerebrospinal venous insufficiency in patients with multiple sclerosis. J Neurol Neurosurg Psychiatry 2009;80(4):392-9)
3 - The value of cerebral Doppler venous haemodynamics in the assessment of multiple sclerosis. They performed the same procedure, but the test was blinded to the sonographer. It involved 109 patients and 177 controls, some of them with other diseases. After dopplers were done they were send to diagnosis numbered. When it was unblinded, they repeated consistently the former result. All MS patients had 2 failures in the battery of doppler tests and only them had this amount of failures. Based on their observations that only MS people had 2 or more failures, they set the current criteria for CCSVI as that value and they published 100% sensitivity and 100% specificity for this test.
4 - BNAC CTEVD: (Combined Transcranial and Extracranial Venous Doppler Evaluation), by Zivadinov. The biggest to date. A randomised controlled study of 499 patients (The study group consisted of 289 persons with MS, 163 healthy controls, 26 with OND, other neurological diseases, and 21 with CIS) confirmed twice as big prevalence of CCSVI in MS patients in comparison with healthy controls. They found that CCSVI prevalence is bigger in MS patients (from 56% to 62%) than in controls (from 22% to 25%). CIS and OND showed intermediate values.
5 - Kuwait Mubarak Al-Kabeir Hospital (Tariq Sinan) [5]: Prevalence of CCSVI in MS patients: 96%.
Source: http://www.ccsvikuwait.com/Details.aspx?d=4
6 - Jordan University of Science and Technology: Study for "Internal jugular vein morphology and hemodynamics in patients with multiple sclerosis". [6], . They found nearly a 90% of prevalence of CCSVI in MS.
Source: http://www.ncbi.nlm.nih.gov/pubmed/20351667
7 - MS Center, Utano National Hospital: Evaluation of blood flow and the cross-sectional area of internal jugular vein in Japanese multiple sclerosis and neuromyelitis optica patients [7]. This study does not support the CCSVI theory in oriental MS cases, pointing towards a heterogeneity for the different variants of MS.
Source: http://www.ncbi.nlm.nih.gov/pubmed/21735737
8 - Albany Vascular Group Study (Dr. Mehta): LIBERATION study. [8] This study is a prospective, randomized, double-blind study that is currently enrolling 600 patients. In the study, investigators performed venograms to identify stenoses of 50% or greater in internal jugular and azygous veins in the patients, all of whom underwent venoplasty. Neurologists and other clinicians evaluated the patients at baseline, and then at 1 month, 3 months, and every 6 months thereafter. The 125 patients included in the study had a mean age of 47 years, and 62% were female. Relapsing-remitting MS accounted for 54% of the patients, followed by secondary-progressive MS in 34% and primary-progressive MS in 12%. The patients had a total of 230 lesions altogether, 90% of which involved the internal jugular veins; the majority of these were at the origin. The remaining 10% of patients had stenoses in their azygous veins. The mean degree of occlusion was about 80%, with approximately 1.8 lesions per patient. Immediate success (defined as less than 20% residual stenosis) occurred in 82%.
Source: http://clinicaltrials.gov/ct2/show/NCT0 ... +ms&rank=1
9 - Austin health hospital, Australia: Prof Brian Chambers, Ms Heather Cameron, Austin Health, Ms Jayne Chambers, Prof Richard Macdonell. Abnormal venous drainage of the brain and spinal cord in patients with MS (preliminary report) [10]. This report yields by now a negative result, finding similar CCSVI incidence in MS patients and controls. More results are expected in ECTRIMS, Amsterdam, October 2011.
Source: http://www.msra.org.au/abnormal-venous- ... atients-ms
10 - Standford study: (comparison of MR and Contrast Venography of the Cervical Venous System in Multiple Sclerosis). Though the main target of the study was to compare CV (contrast venography) and MRI (magnetic resonance imaging) for diagnosis of CCSVI in MS patients, it also showed a correlation between MS and CCSVI because every MS patient had something wrong with their jugular veins (100% prevalence). The lead doctor of the study (Dr. Dake) does not appear as lead author. His data were submited to a blinded neuroradiologist who scored the venous irregularities to avoid any possible bias. American Journal of Neuroradiology published this study.
11 - Mamoon study: prevalence of CCSVI in MS patients: 84%
Source: http://www.ccsvikuwait.com/Details.aspx?d=4
12 - Simka study: Prevalence of CCSVI in MS patients: 95%
Source: http://www.ccsvikuwait.com/Details.aspx?d=4
13 - No cerebrocervical venous congestion in patients with multiple sclerosis: Fifty-six MS patients and 20 controls were studied. Except for 1 patient, blood flow direction in the IJVs and VVs was normal in all subjects. Therefore the prevalence of CCSVI in MS patients after this study is 1/56 [13]. Zamboni wrote a note remarking some possible problems during the study.
Source: http://www.mendeley.com/research/cerebr ... clerosis-1
13 - Katayoun Alikhanim study (University of Calgary). Focusing only in neck vein abnormalities in 67 people (34 MS, 20 not MS, 7 possible MS, 6 CIS) using contrast-enhanced MR venography, with a blinded radiologist, found abnormalities in 7 out of 34 with MS, 4 out of 20 not MS, 0 out of 7 possible MS and 1 out of 6 CIS. They remarked that patients with vein abnormalities were more likely to be older and to have more disability than those with normal veins.
14 - Extracranial venous vessel pathology in multiple sclerosis [14]: Though it also included angioplasty, it is also a prevalence study as it says as conclusion "In all MS patients with the progressive course of disease venous vessel pathology was dicovered". 30 consecutive MS patients (aged 27-73 years) with progressive course of disease – 17 patients with secondary progressive and 13 with primary progressive MS with mean EDSS 5.53 (range 2.0-7.5). Endovascular treatment did not produced any serious side effects. No significant improvement of EDSS score (less than 1.0 point) was noticed, but significant amelioration of the fatigue assessed by FSS (p < 0.001). They used selective venography for detecting stenosis. Source: <shortened url>
15 - Proposed chronic cerebrospinal venous insufficiency criteria do not predict multiple sclerosis risk or severity: CCSVI was studied in 84 MS patients and in 56 healthy subjects by applying the Zamboni method for CCSVI identification. They found no significant differences (p = 0.12) in CCSVI frequency between MS and control subjects. Furthermore, no differences were found between CCSVI-positive and CCSVI-negative patients in terms of relevant clinical variables such as disease duration, time between onset and first relapse, relapsing or progressive disease course, and risk of secondary progression course. Statistically significant differences were not found between CCSVI-positive and CCSVI-negative MS subjects by analyzing direct measures of disability such as mean Expanded Disability Status Scale (EDSS) (p = 0.07), mean progression index (p > 0.1), and mean MS severity score (p > 0.1).
16 - Hypoperfusion of brain parenchyma is associated with the severity of CCSVI in MS patients [15][16]: This study tries to stablish a relationship between CCSVI, measured by doppler, and hypoperfusion, measured by perfusion-weighted MRI. They tested 16 pwMS and 8 healthy controls. The severity of CCSVI was assessed according to the venous hemodynamic insufficiency severity score (VHISS). There was a significant association between increased VHISS and decreased CBF in the majority of examined patients. As prevalence study, is remarkable that Zivadinov, independently from Zamboni, found 100% prevalence of CCSVI in MS patients.
Source: http://www.biomedcentral.com/1741-7015/9/22, http://www.biomedcentral.com/content/pd ... 5-9-22.pdf
* Frankfurt study: "The perfect crime? CCSVI not leaving a trace in MS" [17]. Twenty MS patients were compared with 20 healthy controls. Extra- and intracranial venous flow direction was assessed by colour-coded duplex sonography, and extracranial venous cross-sectional area (VCSA) of the internal jugular and vertebral veins (IJV/VV) was measured in B-mode to assess the five previously proposed CCSVI criteria. IJV-VCSA#0.3 cm2 indicated stenosis, and IJV-VCSA decrease from supine to upright position ‘reverted postural control’. The tests did not provide supportive evidence for the presence of CCSVI in MS patients. Source: http://bit.ly/dRqPnB
Please, add any other trial not listed here (specially negative studies), to keep a track.
1- Intracranial Venous Haemodynamics in MS, 2007, performed by Zamboni's team. They took 89 MS patients and 60 controls looking for flood problems in MS .(Zamboni P, Menegatti E, Bartolomei I, et al. Intracranial venous haemodynamics in multiple sclerosis. Curr Neurovasc Res 2007;4(4):252-8). They identified five anomalous parameters of venous blood back into the brains of people with MS comparing 89 people with MS to 60 controls. They proposed a technique combining TCCS (transcranial color coded duplex sonography) and ECD (Echo color doppler) to meassure the backflows.
2 - Chronic cerebrospinal venous insufficiency in patients with multiple sclerosis (April 2008). Second trial of Zamboni and his third CCSVI related article. They presented 65 people with MS and compared them to 235 control patients, of whom 45 had other neurological diseases. They used five tests with the TCCS-ECD criteria they had devised. They coined the term chronic cerebro-spinal venous insufficiency (CCSVI) for the venous problems they reported (Zamboni P, Galeotti R, Menegatti E, et al. Chronic cerebrospinal venous insufficiency in patients with multiple sclerosis. J Neurol Neurosurg Psychiatry 2009;80(4):392-9)
3 - The value of cerebral Doppler venous haemodynamics in the assessment of multiple sclerosis. They performed the same procedure, but the test was blinded to the sonographer. It involved 109 patients and 177 controls, some of them with other diseases. After dopplers were done they were send to diagnosis numbered. When it was unblinded, they repeated consistently the former result. All MS patients had 2 failures in the battery of doppler tests and only them had this amount of failures. Based on their observations that only MS people had 2 or more failures, they set the current criteria for CCSVI as that value and they published 100% sensitivity and 100% specificity for this test.
4 - BNAC CTEVD: (Combined Transcranial and Extracranial Venous Doppler Evaluation), by Zivadinov. The biggest to date. A randomised controlled study of 499 patients (The study group consisted of 289 persons with MS, 163 healthy controls, 26 with OND, other neurological diseases, and 21 with CIS) confirmed twice as big prevalence of CCSVI in MS patients in comparison with healthy controls. They found that CCSVI prevalence is bigger in MS patients (from 56% to 62%) than in controls (from 22% to 25%). CIS and OND showed intermediate values.
5 - Kuwait Mubarak Al-Kabeir Hospital (Tariq Sinan) [5]: Prevalence of CCSVI in MS patients: 96%.
Source: http://www.ccsvikuwait.com/Details.aspx?d=4
6 - Jordan University of Science and Technology: Study for "Internal jugular vein morphology and hemodynamics in patients with multiple sclerosis". [6], . They found nearly a 90% of prevalence of CCSVI in MS.
Source: http://www.ncbi.nlm.nih.gov/pubmed/20351667
7 - MS Center, Utano National Hospital: Evaluation of blood flow and the cross-sectional area of internal jugular vein in Japanese multiple sclerosis and neuromyelitis optica patients [7]. This study does not support the CCSVI theory in oriental MS cases, pointing towards a heterogeneity for the different variants of MS.
Source: http://www.ncbi.nlm.nih.gov/pubmed/21735737
8 - Albany Vascular Group Study (Dr. Mehta): LIBERATION study. [8] This study is a prospective, randomized, double-blind study that is currently enrolling 600 patients. In the study, investigators performed venograms to identify stenoses of 50% or greater in internal jugular and azygous veins in the patients, all of whom underwent venoplasty. Neurologists and other clinicians evaluated the patients at baseline, and then at 1 month, 3 months, and every 6 months thereafter. The 125 patients included in the study had a mean age of 47 years, and 62% were female. Relapsing-remitting MS accounted for 54% of the patients, followed by secondary-progressive MS in 34% and primary-progressive MS in 12%. The patients had a total of 230 lesions altogether, 90% of which involved the internal jugular veins; the majority of these were at the origin. The remaining 10% of patients had stenoses in their azygous veins. The mean degree of occlusion was about 80%, with approximately 1.8 lesions per patient. Immediate success (defined as less than 20% residual stenosis) occurred in 82%.
Source: http://clinicaltrials.gov/ct2/show/NCT0 ... +ms&rank=1
9 - Austin health hospital, Australia: Prof Brian Chambers, Ms Heather Cameron, Austin Health, Ms Jayne Chambers, Prof Richard Macdonell. Abnormal venous drainage of the brain and spinal cord in patients with MS (preliminary report) [10]. This report yields by now a negative result, finding similar CCSVI incidence in MS patients and controls. More results are expected in ECTRIMS, Amsterdam, October 2011.
Source: http://www.msra.org.au/abnormal-venous- ... atients-ms
10 - Standford study: (comparison of MR and Contrast Venography of the Cervical Venous System in Multiple Sclerosis). Though the main target of the study was to compare CV (contrast venography) and MRI (magnetic resonance imaging) for diagnosis of CCSVI in MS patients, it also showed a correlation between MS and CCSVI because every MS patient had something wrong with their jugular veins (100% prevalence). The lead doctor of the study (Dr. Dake) does not appear as lead author. His data were submited to a blinded neuroradiologist who scored the venous irregularities to avoid any possible bias. American Journal of Neuroradiology published this study.
11 - Mamoon study: prevalence of CCSVI in MS patients: 84%
Source: http://www.ccsvikuwait.com/Details.aspx?d=4
12 - Simka study: Prevalence of CCSVI in MS patients: 95%
Source: http://www.ccsvikuwait.com/Details.aspx?d=4
13 - No cerebrocervical venous congestion in patients with multiple sclerosis: Fifty-six MS patients and 20 controls were studied. Except for 1 patient, blood flow direction in the IJVs and VVs was normal in all subjects. Therefore the prevalence of CCSVI in MS patients after this study is 1/56 [13]. Zamboni wrote a note remarking some possible problems during the study.
Source: http://www.mendeley.com/research/cerebr ... clerosis-1
13 - Katayoun Alikhanim study (University of Calgary). Focusing only in neck vein abnormalities in 67 people (34 MS, 20 not MS, 7 possible MS, 6 CIS) using contrast-enhanced MR venography, with a blinded radiologist, found abnormalities in 7 out of 34 with MS, 4 out of 20 not MS, 0 out of 7 possible MS and 1 out of 6 CIS. They remarked that patients with vein abnormalities were more likely to be older and to have more disability than those with normal veins.
14 - Extracranial venous vessel pathology in multiple sclerosis [14]: Though it also included angioplasty, it is also a prevalence study as it says as conclusion "In all MS patients with the progressive course of disease venous vessel pathology was dicovered". 30 consecutive MS patients (aged 27-73 years) with progressive course of disease – 17 patients with secondary progressive and 13 with primary progressive MS with mean EDSS 5.53 (range 2.0-7.5). Endovascular treatment did not produced any serious side effects. No significant improvement of EDSS score (less than 1.0 point) was noticed, but significant amelioration of the fatigue assessed by FSS (p < 0.001). They used selective venography for detecting stenosis. Source: <shortened url>
15 - Proposed chronic cerebrospinal venous insufficiency criteria do not predict multiple sclerosis risk or severity: CCSVI was studied in 84 MS patients and in 56 healthy subjects by applying the Zamboni method for CCSVI identification. They found no significant differences (p = 0.12) in CCSVI frequency between MS and control subjects. Furthermore, no differences were found between CCSVI-positive and CCSVI-negative patients in terms of relevant clinical variables such as disease duration, time between onset and first relapse, relapsing or progressive disease course, and risk of secondary progression course. Statistically significant differences were not found between CCSVI-positive and CCSVI-negative MS subjects by analyzing direct measures of disability such as mean Expanded Disability Status Scale (EDSS) (p = 0.07), mean progression index (p > 0.1), and mean MS severity score (p > 0.1).
16 - Hypoperfusion of brain parenchyma is associated with the severity of CCSVI in MS patients [15][16]: This study tries to stablish a relationship between CCSVI, measured by doppler, and hypoperfusion, measured by perfusion-weighted MRI. They tested 16 pwMS and 8 healthy controls. The severity of CCSVI was assessed according to the venous hemodynamic insufficiency severity score (VHISS). There was a significant association between increased VHISS and decreased CBF in the majority of examined patients. As prevalence study, is remarkable that Zivadinov, independently from Zamboni, found 100% prevalence of CCSVI in MS patients.
Source: http://www.biomedcentral.com/1741-7015/9/22, http://www.biomedcentral.com/content/pd ... 5-9-22.pdf
* Frankfurt study: "The perfect crime? CCSVI not leaving a trace in MS" [17]. Twenty MS patients were compared with 20 healthy controls. Extra- and intracranial venous flow direction was assessed by colour-coded duplex sonography, and extracranial venous cross-sectional area (VCSA) of the internal jugular and vertebral veins (IJV/VV) was measured in B-mode to assess the five previously proposed CCSVI criteria. IJV-VCSA#0.3 cm2 indicated stenosis, and IJV-VCSA decrease from supine to upright position ‘reverted postural control’. The tests did not provide supportive evidence for the presence of CCSVI in MS patients. Source: http://bit.ly/dRqPnB