WOW is back … in the hospital.
- Thread starter wow
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***UPDATE***
GREAT NEWS!
Two days before Christmas I learned that I am *IN* the TEVA study. Basically, it's a study of a drug and stem cells that are injected into the dead muscle of the heart wall in an attempt to get the body to re-grow the muscle and repair the heart.
The procedure only takes about an hour, and involves an overnight stay for monitoring. My procedure is scheduled for January 6th. I am excited and hopeful!
Now the bad news:
The study is a blind one, with 50% of the participants getting the drug, and 50% not getting it. They don't use a placebo in this study because of the danger of introducing anything into the heart that isn't absolutely necessary. They do most of the procedure identically, but they don't actually inject anything. Everything else is the same.
The study goes for FIVE YEARS!!! I supposedly won't know whether I received the drug and cells until the end of the study, but the reality is that I should be able to tell whether I got it based on how my ejection fraction improves within 3-6 months - or not.
I have my fingers crossed that I am one of the lucky 50%!!!
GREAT NEWS!
Two days before Christmas I learned that I am *IN* the TEVA study. Basically, it's a study of a drug and stem cells that are injected into the dead muscle of the heart wall in an attempt to get the body to re-grow the muscle and repair the heart.
The procedure only takes about an hour, and involves an overnight stay for monitoring. My procedure is scheduled for January 6th. I am excited and hopeful!
Now the bad news:
The study is a blind one, with 50% of the participants getting the drug, and 50% not getting it. They don't use a placebo in this study because of the danger of introducing anything into the heart that isn't absolutely necessary. They do most of the procedure identically, but they don't actually inject anything. Everything else is the same.
The study goes for FIVE YEARS!!! I supposedly won't know whether I received the drug and cells until the end of the study, but the reality is that I should be able to tell whether I got it based on how my ejection fraction improves within 3-6 months - or not.
I have my fingers crossed that I am one of the lucky 50%!!!
jmbfestool
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wow said:
[eek] I hope you are one of the 50%
Good luck!
CrazyLarry
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Wow that brings a whole new meaning to the phrase 'life's a lottery'! Here's hoping you do get in the 50% at least that's a whole 50% better than not being on the program at all 
It feels like a tough break on those who just go through the motions for 5 years...
If after 3 months if you don't suddenly feel like you're recovered and taking up marathon running can you grow a moustache, wear a wig and rejoin the program with a new name?
Maybe you need to deploy some of that heavy weight culinary bribery in advance!!!
It feels like a tough break on those who just go through the motions for 5 years...
If after 3 months if you don't suddenly feel like you're recovered and taking up marathon running can you grow a moustache, wear a wig and rejoin the program with a new name?
Maybe you need to deploy some of that heavy weight culinary bribery in advance!!!
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I should mention that my 'backup plan' is to get a bi-valve pacemaker/ICD implanted. I am already approved for that procedure, but won't be able to do that for six months after the study begins in order to keep the data 'pure'.
All of this ASSUMES that my health does not change significantly, of course. Should I experience what they call a 'MACE' event (Major Adverse Cardiac Event) everything could change.
All of this ASSUMES that my health does not change significantly, of course. Should I experience what they call a 'MACE' event (Major Adverse Cardiac Event) everything could change.
Gary in Texas
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Wayne, hopefully you will be one of the chosen 50%! If your doctor got your into the program, he may have enough influence to ensure that is the case. Best of luck!!!!
Remember that part of the idea of a blind study is to discover side effects, which could potentially be worse than the procedure being tested.
Wayne described this as a blind, and not a double blind test. But, I would think that to preserve the integrity of the process, only the staff performing the operation would know if they performed the injection. Your regular doc should not be informed.
Wayne described this as a blind, and not a double blind test. But, I would think that to preserve the integrity of the process, only the staff performing the operation would know if they performed the injection. Your regular doc should not be informed.
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Stoli said:
This a phase 3 trial, which is generally the last step before FDA approval. The risk is quite low.
The only people that I deal with who will know whether I get the 'good stuff' or not are one study coordinator and one of my cardiac Docs who happens to be THE Doctor who oversees this study for the Heart Hospital. The reason that there are two 'local' people who know is because - if I DO experience a MACE event - there are two 'local' people that the Emergency Team can contact to find out whether the event might be related to the study or not. Of course that's in addition to them being able to contact the study company themselves in an emergency.
I understand and appreciate the concern!!! I am quite comfortable with the plan, the study, and my care. I just hope that I get the 'good stuff', as the alternatives are not that great for long-term outcome otherwise...
Sparktrician
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Best of luck, Wayne!!! Hope this lottery goes in your favor.
[smile]
[smile]
Stephen B
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[size=14pt]
Two quotes come to mind when I read this Wayne.
Clint Eastwood, 'You feeling lucky punk'.
My Grandmother, 'What's life without a risk'.
Best wishes Wayne for a successful participation in this trial and subsequent improvement in your ability to enjoy your Festools (and Mrs WOWs fudge [smile] ).
Two quotes come to mind when I read this Wayne.
Clint Eastwood, 'You feeling lucky punk'.
My Grandmother, 'What's life without a risk'.
Best wishes Wayne for a successful participation in this trial and subsequent improvement in your ability to enjoy your Festools (and Mrs WOWs fudge [smile] ).
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Wayne,
I also hope that you are one of the lucky 50% and that your health situation can be improved. Crossing my fingers and saying a prayer for you.
Peter
I also hope that you are one of the lucky 50% and that your health situation can be improved. Crossing my fingers and saying a prayer for you.
Peter
wow,
I wish you 100% good luck with the 50%.
You are always 100% with your comments and help here on the FOG.
Years ago, I came across a little short article in, I think, Reader's Digest, titled "What's in a Name." One of the names mentioned was "Wayne". Since i happened to have had a personal interest, I remembered that the origin to our name goes back to the days of horse and buggy, or to a time even before. Wayne was a wagon maker, to be more specific, a wainwright. Eventually, the name was narrowed down more specifically to a wheel maker. So, you are used to the spinning of wheels by inheritance. So, you are not worried about 50%. with your outlook, I'm sure you are looking at 50% as 100%.
We are all with you all the way.
Tinker
I wish you 100% good luck with the 50%.
You are always 100% with your comments and help here on the FOG.
Years ago, I came across a little short article in, I think, Reader's Digest, titled "What's in a Name." One of the names mentioned was "Wayne". Since i happened to have had a personal interest, I remembered that the origin to our name goes back to the days of horse and buggy, or to a time even before. Wayne was a wagon maker, to be more specific, a wainwright. Eventually, the name was narrowed down more specifically to a wheel maker. So, you are used to the spinning of wheels by inheritance. So, you are not worried about 50%. with your outlook, I'm sure you are looking at 50% as 100%.
We are all with you all the way.
Tinker
