Remote Ischemic Preconditioning in Patients Undergoing Isolated Aortic Valve Replacement Surgery

Not Applicable

Terminated

• Conditions: Aortic Valve Disease; Myocardial Ischemia
• Interventions: Procedure: Remote ischemic preconditioning

• Registration Number: NCT02694016
• Lead Sponsor: Oulu University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-18
• Study First Submitted QC: 2016-02-26
• Study First Posted: 2016-02-29
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-03
• Last Update Posted: 2018-04-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Neuropsychological assesment	1 month postoperatively	Rey Auditory Verbal Learning Test (RAVLT)

Secondary Outcome Measures

Name	Time	Method
Tissue specific markers analysed from plasma	A day before surgery, during surgery, 24hour and 48hour postoperatively	A bioplex/multiplex assay of neuronal and cardiac tissue specific biomarkers including but not limited to: S-100b, Glial Fibrillary acidic protein, Neuron Specific enolase, Troponin-I, Brain Natriuretic Peptide, Creatinine Kinase - MB
Inflammation markers analysed from plasma and tissue samples	A day before surgery, during surgery, 24hour and 48hour postoperatively	A bioplex/multiplex assay of systemic inflammatory response markers and other cytokines including but not limited to: Tumor Necrosis Factor-a, Interleukin-1b, -2, -4, -5, -6. C-Reactive Protein, Hypoxia inducible Factor -1.

Trial Locations

Locations (1)

Oulu University Hospital, Department of Cardiothoracic surgery; 🇫🇮 Oulu, Finland