| STUDY PROTOCOL |
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| Year : 2016 | Volume
: 1
| Issue : 4 | Page : 149-153 |
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Oxidative stress response in patients with severe aortic stenosis undergoing transcatheter or surgical aortic valve replacement: protocol for a prospective observational study
Gabriel Maluenda1, Nick Curzen2, Michael Mahmoudi M.D., Ph.D. 2
1 Faculty of Medicine, San Borja Arriaran Hospital, Santiago, Chile
2 University Hospital Southampton & Faculty of Medicine, University of Southampton, Southampton, United Kingdom
Correspondence Address:
Michael Mahmoudi
University Hospital Southampton & Faculty of Medicine, University of Southampton, Southampton
United Kingdom
 Source of Support: This study was supported by the "National Funding for Scientific & Technological Development", Santiago, Chile (to GM)., Conflict of Interest: None  | Check |
DOI: 10.4103/2468-5658.196983
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Background: Myocardial ischemia and reperfusion injury mediated by reactive oxygen species (ROS) related to cardiopulmonary bypass has been linked to adverse clinical outcomes following cardiac surgery. The generation of ROS and its clinical impact in patients undergoing transcatheter aortic valve replacement (TAVR) have not been studied.
Methods/Design: This is a prospective observational study that will compare the generation of ROS between 12 consecutive patients undergoing TAVR and 12 patients undergoing isolated surgical aortic valve replacement (SAVR) and will determine whether any potential differences are related to the 3-month composite endpoints of cardiovascular mortality, myocardial infarction, stroke, major bleeding or life threatening bleeding. Peripheral blood will be taken immediately before aortic intervention, at the completion of the procedure, 6-8 hours after the procedure, and 24 hours after the procedure for measurements of ROS. Clinical follow-up at 3 months post discharge will be undertaken either in the outpatient clinic or by telephone.
Discussion: This study will determine changes in the levels of ROS in patients undergoing TAVR and identify whether any potential changes are correlated with clinical outcomes.
Trial registration: ClinicalTrials.gov identifier: NCT02841917; registered on December 29, 2015.
Ethics: The study protocol has been approved by the RES Committee North West Liverpool East (IRAS Project ID: 206946).
Informed consent: Signed informed consent will be obtained from each patient who wishes to participate in this study. |
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