NCT02694016

Remote Ischemic Preconditioning in Patients Undergoing Isolated Aortic Valve Replacement Surgery

Remote Ischemic Preconditioning in Patients Undergoing Isolated Aortic Valve Replacement Surgery With a Biological Prosthesis: A Single Center Randomized Prospective Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Oulu University Hospital · Academic / Other
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal is to investigate the efficacy, safety and possible neuro- and cardioprotective effects of remote ischemic preconditioning (RIPC) in adult cardiac patients undergoing isolated aortic valve replacement surgery with a biological prosthesis. Neuropsychological evaluation preoperatively and at 30d after surgery will establish if there are any differences in neuropsychological performance between groups. A large array of biochemical markers will be analyzed from plasma samples taken at different time points. Additionally skin biopsies from the lower limb will be taken before and after performing RIPC on said limb. During the venous cannulation phase a atrial biopsy will be taken. The biochemical markers from plasma and tissue samples will be used to asses brain tissue damage, inflammation and cardiac tissue damage between groups. This will be a single center prospective randomized study with two groups. A intervention group (RIPC) and a control group. Study size is: 40 patients in total, 20 patients per group.

Conditions

• Aortic Valve Disease
• Myocardial Ischemia

Interventions

Type	Name	Description
PROCEDURE	Remote ischemic preconditioning	A blood pressure cuff is placed around the right leg on the level of the thigh. Randomization is performed after this, using sealed envelopes with covariate balancing for age and sex. Regardless of the outcome of the randomization the cuff is left in place so as not to give any indication of which group the patient belongs to. If the patient is randomized into the remote ischemic preconditioning group (RIPC) then four (4) cycles of five (5) minute inflation are given after induction. Each cycle is followed by a five (5) minute interval of reperfusion. Cuff pressure should be 200mgHg at least (RRsyt + 100mmgHg) during the inflation periods.

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2016-02-29
• Last updated: 2018-04-04

Locations

1 site across 1 country: Finland