Note from Dr. Sandy McDonald:
Sunday September 11 2011
The study I will be doing is not in conjunction with anyone else.
The protocol title is as follows
“An observational study using doppler duplex ultrasound quantifying the occurrence of jugular vein re-stenosis and complications following angioplasty to treat chronic cerebral spinal venous insufficiency (CCSVI)“
This study has IRB approval but does not allow me to do angioplasty--
This study allows me to do follow-up duplex ultrasound on pts pre and post treatment done elsewhere. This study does not endorse any specific treating facility.
I hope to get the study underway this fall
I hope this clarifies any misconception.
Thanks for your help. S
HappyPoet wrote:Cece, Dr. Zamboni was quoted somewhere as saying there would be over 10,000 CCSVI studies in the next ten years.
Dr. Sandy McDonald, a cardiovascular surgeon in Barrie, Ont., hopes to recruit 250 MS patients for the study, which is aimed at assessing the results of the procedure to unblock neck veins.
When MS patients seek the vein-clearing procedure at clinics outside Canada, there is little or no formal followup after they return home — so information about the condition of their neck veins, possible adverse effects and measures of whether the procedure alleviated symptoms are all lost, McDonald said.
"And what I'm trying to do is capture some of the data so that data isn't lost."
As part of the study, McDonald's clinic will repeat the ultrasound imaging to see if vein abnormalities have been corrected and to identify any complications, such as a blood clot that could result in a reblocking of the vein.
"Unless you do a followup study, you don't know if a patient has that," said McDonald. "And if the patient has that, the question is: should it be treated as a standard DVT (deep vein thrombosis)? And my thought is it probably should."
McDonald is conducting his study in association with the U.S.-based Hubbard Foundation, which has international ethics approval for such research.
McDonald said he is not receiving funding for his study, and patients will have to pay for their ultrasound assessment.
“We have two different studies,” said Angela Legace, chief stenographer and office manager at Barrie Vascular Imaging.
Patients can call the office to see if they qualify. Then a baseline ultrasound will be done to check their veins.
“We didn’t get government funding for it. It costs $250,” said Legace.
Then, the patient is asked to find his or her own clinic in the United States or abroad to have the angioplasty surgery done. Legace said the office doesn’t make referrals, it’s up to the patient to choose a clinic to get the surgery done.
The patient will then return to the Barrie clinic to have follow-up ultrasounds post surgery.
“It’s an observational study. So we can find out does this work or doesn’t it. No one’s allowing the treatment yet,” said Legace. “Hopefully the government turns around and tells us we can do it. But it has to be proved first.”
She said the ultrasounds would likely be done after six months, a year and 18 months, so the study should be wrapped up by 2013. “The data will show what happens over time. Do complications show up later? Does it matter where they had the surgery done or the size of balloon used?”
The second study is to follow anyone who has had the CCSVI liberation treatment. There’s no patient limit to that study, said Legace. “It will give us more statistical data on any complications. It doesn’t matter where you got it done.”
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