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Table 2 Schedule of Events

From: Efficacies of the new Paclitaxel-eluting Coroflex Please™ Stent in percutaneous coronary intervention; comparison of efficacy between Coroflex Please™ and Taxus™ (ECO-PLEASANT) trial: study rationale and design

 

Baseline

Post-Procedure

Follow up

   

30 days

4 mo

9 mo

Yearly

   

±2 w

± 1 m

± 3 m

Up to 3 yrs

Medical/Clinical History

X

     

Informed consent

X 1

     

Inclusion/Exlusion Criteria

X

     

Brief Physical Examination

X

     

Vital status

X

     

Weight, height

X

     

12 lead ECG

X 4

   

X

 

Angiogram

X

X

  

X 5

 

CBC

X

     

Electrolytes, LFT, Creatinine, BUN

X

     

hs-CRP

X

     

Fasting plasma triglycerides, HDL, total cholesterol

X

     

Fasting glucose level2

X

     

HgbA1C3

X

     

Pregnancy test (if applicable)

X

     

Medications

X

 

X

X

X

X

CK, CK-MB, Troponin I6

X

X

    

Pro-BNP or BNP

X

     

Event monitoring

X

X

X

X

X

X

  1. 1The informed consent may be signed either prior to the diagnostic angiogram or after the diagnostic angiogram.
  2. 2It may be done later, before discharge when the patient is in a fasting state
  3. 3In patients with diagnosed diabetes mellitus.
  4. 4Additional ECGs will be performed at 60 ± 30 minutes post-procedure. If the patient develops recurrent chest pain, ischemia, or significant arrhythmias, heart failure or other signs or symptoms of clinical instability, additional ECGs should be obtained
  5. 5Routine follow up angiography will be recommended at 9 months, but it can be performed at 9 months ± 3 months. Unscheduled angiograms > 6 months after index procedure will be considered as 9-month follow-up angiogram in final analysis.
  6. 6Optional in selected centers and if baseline lab is done, enzymes must be followed every 8-hours for 24 hours post-index procedure.
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