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| * Click
here to download slides describing
the basic protocol and study design before
completing this questionnaire. Should
you be interested
in participating in this trial, please complete this
questionnaire and click "Submit" below. Once
we receive the questionnaire, we will send
a confidentiality agreement to your site
for signature. |
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| 1. |
How many patients with the diagnosis
of unstable angina/non ST segment elevation MI (UA/NSTEMI)
present
at your center annually?
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| 2. |
What proportion of these patients with UA/NSTEMI
undergo an angiogram within 3 days (72hours) of admission?
% |
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| 3. |
Of the patients who undergo an angiogram, what proportion
undergo: |
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PCI?
% CABG?
% Medical Therapy Only?
% |
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| 4. |
Was your Site/Institution involved in the REPLACE-2
Trial? Yes
No
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If Yes, how many patients enrolled:
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| 5. |
Is your Site participating or intending to participate
in the following trials? |
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SYNERGY: |
Yes
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No
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If Yes, anticipated enrollment stop date:
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A TO Z: |
Yes
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No
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If Yes, anticipated enrollment stop date:
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OASIS 5: |
Yes
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No
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If Yes, anticipated enrollment stop date:
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Other: |
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| 6. |
How often does your IRB typically meet? |
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More frequently than once a month |
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Once a month |
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Once every two months |
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Other |
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How Often: |
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| 7. |
Does your site have internet capabilities required
for electronic data capture (EDC)? |
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Yes No
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| 8. |
After you submit this protocol to your IRB, how long
do you anticipate it will take for both IRB approval
and hospital/group study contracts to be signed (i.e.
the duration until you can begin enrolling patients)? |
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IRB |
Contracts |
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less than 1 month |
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1-2 months |
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2-3 months |
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3-4 months |
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more than 4 months |
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| 9. |
As this trial takes place in the ACS (Emergency Room)
setting, will there be a problem obtaining a signed
consent form from the patient? |
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Yes
No
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If Yes, please provide more detail in the comments
section on how this problem could be addressed at your
site/institution: |
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Comments: |
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| 10. |
Do you anticipate randomizing patients who present: |
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a. At your interventional hospital(s) |
Yes
No
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b. At non-invasive referral hospitals prior to transfer |
Yes
No
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(requires consent and study drug administration prior
to transfer) |
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c. Both sources |
Yes
No
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| 11. |
To facilitate early randomization and study drug
administration: |
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Could ER physicians and/or fellows consent/randomize
patients before the cardiologist/interventionalist? |
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Yes No
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| 12. |
The ACUITY study design requires antithrombotic assignment
and upstream GPIIb/IIIa in the ACS setting. Do you
anticipate your site/institution will be able to randomize
and treat patients this way? |
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Yes No
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If no, please provide further detail in the comments
section below: |
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Comments: |
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| 13. |
Do you have on-site cardiac surgery capabilities? |
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Yes No
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If No, do you have an arrangement with neighboring
facility? |
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Yes No
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| 14. |
Will monitors and auditors have access to source
documents in the surgical department? |
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Yes No
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| 15. |
How many patients do you expect your site/institution
to enroll per month:
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