mean there are various ways that MIs are adjudicated, if you really do it up front and care
about pre-specifying. One typical approach would be to say that you need two out of
three of CPK elevation, ECG abnormality, and clinical symptoms. That’s a typical
approach, there are others, but you certainly could not say that, with only a CPK, it is not
an MI. What you could say is that, as has been discussed and I think well, it’s not
specific for an MI and there are other things that could cause it.
Alexander from Duke had brought it up, and being a pediatric endocrinologist, I don’t see
CPK too often or MIs for that matter. Is it safe to say or agreed upon that if you have an
elevation in your CPK, but you have no EKG findings, that that is not a cardiac event, is
that a -- can you say that?
a concern and it’s a possible MI. I don’t know, how and where to titrate it. I think the
discussion was very good, there are a number of other possible reasons for a CPK and
without the other documentation you are left with a great deal of uncertainty.
DR. KONSTAM: No, you can’t say that. What you can say is that, I
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DR. KONSTAM: Well you just said it a little bit differently, I mean…
DR. FELNER: Well, that was to say, after you made your comment, that
DR. FELNER: Yeah. Just because the cardiologists, I think Dr.
DR. BURMAN: Thank you. Any other questions from the Committee?
DR. FELNER: Without clinical symptoms and without EKG findings, an
elevated CPK, it means very little, correct?
was what I want to add on because…