Italian multicenter study on venous hemodynamics in multiple sclerosis: Advanced Sonological Protocol
Introduction: Because of the recent hypothesis of involvement of the venous hemodynamics in multiple sclerosis (MS), and because of the pitfalls of these studies, there is the need to achieve a definite conclusion from a large sample of subjects by using a strict and controlled neurosonological protocol. The aim of the advanced protocol, designed for a subgroup of the FISM study, is to analyze several items of the venous hemodynamics in order to obtain more pathophysiological data on venous circulation. Advanced Ultrasound Protocol: This is a multicenter, observational study. From a pool of about 1200 adults with MS, 400 healthy subjects and 400 subjects with other neurodegenerative disorders (2000 subjects in total) will be selected a population able to be examined by the advanced protocol. The examiner will always be blind on the clinical diagnosis, and the exams will be performed according to a standard protocol, whose measurements are mandatory for all participating centers. The advanced protocol is on a voluntary basis and it is optional. It includes, besides the basic one, measurements of blood flow volumes in carotid and vertebral arteries and in jugular and vertebral veins (inflow and outflow), with the definition of the drainage pattern. The ultrasound examination at each clinical site will be followed by a second centralized blinded evaluation. The prevalence of CCSVI in MS will be estimated, with confidence intervals at 95%, and compared with the prevalence in other groups. Moreover, multiple analysis will be done comparing venous hemodynamics in the three different groups.
The article is available in full, with images, but I haven't had a chance to read it.