Dr. Mehta in Albany, NY - Thank you, Kacey!

[smokey]

wish I lived in Albany! Sigh.
Do you know of any clinical trials in Australia?

[FlashHack]

Mehta's trial posted:

http://clinicaltrials.gov/ct2/show/NCT0 ... svi&rank=1

[bmk1234]

Mehta's trial posted:

http://clinicaltrials.gov/ct2/show/NCT0 ... svi&rank=1

Is it safe to assume the 500 participants have already been contacted?

[FlashHack]

Not sure what you mean by contacted. In my limited experience, no study I have signed up for to date has provided any information other than letting me know that it has received my information. At this point I don't expect to hear from anyone until they call to schedule my visit. Unfortunately, they don't have a public relations person, only clinicians.

[TFau]

"The evaluation of safety will be defined as the incidence of major adverse events at 30 days following the index procedure. The evaluation of feasibility and efficacy will be determined by those patients that do not have more than 50 percent restenosis within the 30 day time frame."

OMG - does this mean what I think it means? They will be evaluating for safety AND efficacy at 30 days as a primary outcome measure? If the procedure is sufficiently efficacious at this point, it is then unethical to not treat patients, correct? Somebody who has been following clinical trial study designs pinch me please!

This could be great news since symptoms such as fatigue, cold extremities, spasticity, etc seem to be alleviated in that time frame...

[mshusband]

I think the bigger statement therein is ...

"Intervention Details:

Procedure: Angioplasty
To identify the presence of CCSVI, all patients will undergo a clinical evaluation by a neurologist, a duplex ultrasound of central extracranial venous system, an MRV, and a venogram. The decision to enroll patient in percutaneous angioplasty for CCSVI will be made at the time of venogram, in select patients that have greater than or equal to 50 percent stenosis of the extracranial central veins including the internal jugular veins and the azygos vein. Extracranial venous ultrasound will be performed at 3, 6, 12, 18, and 24 months following the procedure or if clinical symptoms recur. MRV and venograms will be performed at 12months and 24 months or if clinical symptoms recur."

That meaning, they know it's going to work in the short term ... let's see about the longer term and see what/why it happens.

I think they also mentioned 2nd treatments if restenosis occurred.


VERY EXCITING STUDY!!! (Too bad there even has to be a study).

[Lyon]

.

[TFau]

I'm excited to see the 30 day endpoint because I'm hoping that proven efficacy of any symptom at that point will cause the Ontario government to lift the experimental status of the treatment, which in turn hopefully will allow vascular surgeons to perform the procedure.

[jr5646]

Some more info. on Dr. Mehta - all positive if you ask me..

http://vaware.org/home.html

WHO WE ARE
The Center for Vascular Awareness, Inc is a 501(c)(3) not for profit organization dedicated to fostering mainstream consumer and clinical consciousness of vascular health standards, disease, prevention and treatment options.

PDF: The Journal of the Center for Vascular Awareness - Jump to page 18 CCSVI and MS

PDF LINK

Good article regarding the study - too bad Colin Rose had to leave a nasty comment...

LINK

[Cece]

Not to bring you to task because everyone has a right to their opinion but I am curious as to the reasons you feel that studies are an impediment to progress?

It pains me sometimes but I have to agree with Lyon on this...although this next part he may not agree with me...it is the studies that are going to prove the legitimacy of CCSVI and blow this sky-high, so that every person with m.s. and every person with a close relative with m.s. will have access to being tested and, if indicated, treated. Studies are beautiful things and they cannot come quick enough, in my opinion! And wow is Dr. Mehta being thorough, with all the follow-up ultrasounds and MRVs and venograms. Hats off to him....

[mshusband]

Let me clarify I guess.

I agree studies are a great thing because that's how this treatment will become standard protocol.

I was meaning too bad there even has to be a study because all of this (venous malformations as the CAUSE of MS) were hypothesized decades ago - and by now should have been more thoroughly investigated, while neuros looked into the "mystery".

Yet Neurologists still seem to think this is a "mysterious" disease that they can't explain. Yet they have no evidence this is a "disease" at all.

Yes there is a neurological reaction to something happening ... but what if that's just because there's something going on in the body that shouldn't be going on in the first place. Yet they don't want to hear that.

That's all I was trying to say.


I mean think about it ... how many hundreds/thousands of years did man think he could build flying machines (probably from the first time one saw a bird fly) ... yet it took two brothers from Ohio (no smarter than average men mind you) to do it.

Couldn't the same be said about finding this "mysterious" cause of MS. I wouldn't say Zamboni is the smartest man in the world (I'm sure he'd say as much) but he had a drive and passion/reason to find out what MS was ...

It's the same story.

Breakthroughs happen all at once (even though they were hypothesized long before) ... just like Da Vinci drawing helicopters long before one was ever built.

[Lyon]

.

[Cece]

I was meaning too bad there even has to be a study because all of this (venous malformations as the CAUSE of MS) were hypothesized decades ago - and by now should have been more thoroughly investigated, while neuros looked into the "mystery".

I agree completely: if it's this simple, why did it take so long?

[HappyPoet]

Here is the link to a July '09 interview with Dr. Mehta:

http://vaware.org/news/69-manishmethain ... nwnyt.html

[sald]

Hi Guys,

Any more news on Dr. Mehta's trial???

I enrolled in Mar, 2010....

Many thanks,

Sal