PREPARE
Research type
Research Study
Full title
PREssure Wire PullbAck in REal Time (PREPARE)
IRAS ID
151670
Contact name
Justin Davies
Contact email
Research summary
Cardiologists often use a wire in the heart arteries to measure pressure changes within them. This process, called a ’pressure wire pullback’ lets Doctors know which parts of the artery need treatment with a stent, and which parts can be left alone.
We have developed mathematical algorithms to analyse the information from the pressure wire pullback in a more detailed way than normally available. The algorithms help predict what length of stent will be needed and what the effect of the stent will be.
This study will simply compare the two different mathematical algorithms in patients who are undergoing the procedure as part of their normal routine clinical care.
At present we have two mathematical algorithms. The first is performed on specialist computer equipment and gives a great deal of information, but has to be analysed after the procedure has finished(’Offline’ pullback). The second is integrated into the clinical equipment we routinely use and gives information to the Doctor as the pressure wire test is conducted (’Real Time’ pullback).
Patients undergoing assessment and treatment for routine clinical reasons will be asked to participate. We are asking them for permission to process the pressure wire information by the two different algorithms and the outputs to be compared. All other patient care will be as routinely clinically required. Since the data, which is routinely acquired in every case using a pressure wire, is simply being processed by computer algorithms, patients are not exposed to any additional risk over their normal procedure.
The study allows us to see if there are any discrepancies between the two approaches, and see if both provide equivalent information. This will help support further development of algorithms and future larger studies.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
14/EM/0151
Date of REC Opinion
2 Apr 2014
REC opinion
Favourable Opinion