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There are approximately 11,000-13,000 people in Alberta with multiple sclerosis
(MS). Many are known to be seeking an unproven surgical intervention for a condition
called chronic cerebrospinal venous insufficiency (CCSVI). The intervention (treatment)
may consist of either an angioplasty (a procedure used to widen a blood vessel)
or an angioplasty with placement of venous stents (metal tubes used to hold the
vessel open). Neither venous stents, nor venous angioplasty, are approved in Canada
so people with MS are going out of the country and paying to have these interventions
done. They are then returning to Canada for follow-up and ongoing management. Some
individuals report that they have had outstanding improvements; others report that
they have had little or no change. Some patients are experiencing complications.
In Alberta, this information on patient reported symptom changes and complications
is not currently being collected and analyzed systematically.
Following a meeting between the Minister of Health and Wellness, physicians, researchers,
and representatives of the MS community in Alberta who had undergone CCSVI therapy,
the University of Calgary was asked to take the lead in putting together an observational
study. An observational study requires data gathering but no testing or treatments
are given. This study is being referred to as The Alberta Multiple Sclerosis Initiative
(or TAMSI for short).
What is The Purpose of the Study?
The main purpose of TAMSI is to gather evidence to improve the understanding of
CCSVI treatment. It aims to determine the safety of the various treatments being
used and describe the range of experiences and outcomes of these treatments. This
information is critical in helping to determine appropriate care after CCSVI treatments.
It is also necessary to guide the design of clinical trials of CCSVI treatments
and to interpret the clinical trial results.
TAMSI will also obtain information from people with MS and related conditions who
have not had CCSVI treatment and from people without MS who have had CCSVI treatment.
Various treatments for CCSVI will be compared. This project, in combination with
other ongoing research, may in the future lead to a provincially organized randomized
controlled intervention trial of CCSVI therapy.
This study will also have other benefits that are unrelated to CCSVI making it extremely
helpful if all people with MS participate. It will provide information about the
health status and living situation of all Albertans with MS and will allow comparison
of information provided by people with MS with information from health records and
information that can be obtained from provincial health registries, otherwise known
as administrative databases. (Administrative databases store coded information about
medical services provided to you. For example, if you see a physician, the date
and location of the visit, the diagnosis assigned by the physician, and the physician
you saw would be recorded. Also, if you had a telephone visit with a multiple sclerosis
clinic nurse, similar information would be collected.)
Data obtained in this study will, for example, allow a description of the Alberta
MS population by descriptors such as age, geographical location, disability group,
and the rate of other medical conditions. This will be useful in planning health
services. By comparing data from different sources we will be able to get a more
complete picture and determine how well health registry data can be used to detect
outcomes following the introduction of new treatments in MS.
This study will also help more Albertans become involved in the research process.
You will be asked to indicate if we can contact you by email about other research
studies that have already been approved by an Alberta health research ethics board.
We also hope this study will be the start of a long-term study of MS in Alberta.
However, the data that you provide will not be used for any other study, including
an extension of this study, without your consent. You are not being asked for your
consent at this time for any future studies.