Remote Ischemic Preconditioning in Patients Undergoing Isolated Aortic Valve Replacement Surgery

Oulu University Hospital

Status: Terminated

Conditions: Myocardial Ischemia; Aortic Valve Disease

Treatments: Procedure: Remote ischemic preconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT02694016

RIPC00AVR

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

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
• Difference in cardioplegic protocol
• Diseased aorta in epiaortic ultrasound

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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4 participants in 2 patient groups

Remote ischemic preconditioning

Experimental group

Description:

Patient will undergo normal isolated aortic valve replacement surgery with a biological prosthesis and a preoperative lower leg remote ischemic preconditioning(RIPC) phase.

Treatment:

Procedure: Remote ischemic preconditioning

Control group

No Intervention group

Description:

Patient will undergo normal isolated aortic valve replacement surgery with a biological prosthesis