Remote Ischemic Preconditioning in Patients Undergoing Isolated Aortic Valve Replacement Surgery With a Biological Prosthesis: A Single Center Randomized Prospective Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Valve Disease
- Sponsor
- Oulu University Hospital
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Neuropsychological assesment
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
Brief 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.
Investigators
Fredrik Yannopoulos
Resident
Oulu University Hospital
Eligibility Criteria
Inclusion Criteria
- •Non-emergency aortic valve replacement with a biological prosthesis with perfusion and cardiac arrest
Exclusion Criteria
- •Recent myocardial infarction
- •Carotid stenosis requiring intervention
- •Any other concomitant surgical procedure
- •Increased troponin baseline before surgery
- •Critical ischemia of lower limbs
- •Peripheral arterial disease (ASO, media sclerosis)
- •Morbid obesity (Incompatible cuff-to-thigh diameter)
- •Severe heart insufficiency
- •Moderate to severe venous insufficiency lower limbs
- •Recent acute stroke \<90d
Outcomes
Primary Outcomes
Neuropsychological assesment
Time Frame: 1 month postoperatively
Rey Auditory Verbal Learning Test (RAVLT)
Secondary Outcomes
- Tissue specific markers analysed from plasma(A day before surgery, during surgery, 24hour and 48hour postoperatively)
- Inflammation markers analysed from plasma and tissue samples(A day before surgery, during surgery, 24hour and 48hour postoperatively)