Dr.Tarak Parikh
☆    

India,
2007-05-22 15:56
(6979 d 02:58 ago)

Posting: # 737
Views: 4,643
 

 QTc study [Design Issues]

Hello,
I have a quiry , we have got the USFDA approved ECG machines so the ECG comes with the QTc interval(counted). so
1. are we require to read that ECG manually for counting QTc interval?
if yes then can any body tell me the formula ?
the method...the design of study....etc....
if any body can provide me a guideline on this , i ll be greatful to them.
thankyou..
regards
Dr.Tarak
Ohlbe
★★★

France,
2007-05-25 00:50
(6976 d 18:04 ago)

@ Dr.Tarak Parikh
Posting: # 738
Views: 3,720
 

 QTc study

Dear Dr. Tarak,

You will find some answers to your questions, including formulae for the calculation of QTc, in the ICH E14 guideline.

Regards
Ohlbe
gagandeep
●    

2007-06-08 10:15
(6962 d 08:39 ago)

@ Dr.Tarak Parikh
Posting: # 792
Views: 3,771
 

 QTc study

Dear Tarak,

1. I have noted that even in calibrated machines, HR is not representated accurately. Hence while checking Medical Screening Records, I have manually counted the heart rate using the RR interval formula. I counted RR interval between 3 or more beats, took average and verified the HR. This helped me in choosing volunteers and keeping them within study, with sinus bradycardia which was acceptable, otherwise the subjects were to be rejected based on machine calculations for low HR. I do not rely on machines at all (they do not do the average calcs in my opinion).

2. I suggest you devise excel sheet in following manner:
in cell 1, place the QT interval
Cell 2 - RR interval
Cell 3- place formula which will calculate sq root of cell 2
Cell 4 is = cell 1 divided by cell 3 and this is your QTC - so simple!!

Revert back for any clarifications

Dr. Gagandeep Singh
Senior Consultant
Domain Consulting Team - Lifesciences
Cognizant Technology Solutions
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