Remote Ischemic Preconditioning in Patients Undergoing Isolated Aortic Valve Replacement Surgery

NCT ID: NCT02694016

Last Updated: 2018-04-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2017-12-31

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.

Conditions

Aortic Valve Disease; Myocardial Ischemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Remote ischemic preconditioning

Intervention Type: PROCEDURE

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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

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
• Difference in cardioplegic protocol
• Diseased aorta in epiaortic ultrasound

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oulu University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Fredrik Yannopoulos

Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fredrik Yannopoulos, MD Ph.D

Role: STUDY_DIRECTOR

Oulu University Hospital

Vesa Anttila, MD Ph.D.

Role: STUDY_CHAIR

Oulu University Hospital

Tuomas Ahvenvaara, MD

Role: PRINCIPAL_INVESTIGATOR

Oulu University Hospital

Tuomas Mäkelä, MD.Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Oulu University Hospital

Locations

Oulu University Hospital, Department of Cardiothoracic surgery

Oulu, , Finland

Countries

Finland

Other Identifiers

RIPC00AVR

Identifier Type: -

Identifier Source: org_study_id