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Remote Ischemic Preconditioning in Patients Undergoing Isolated Aortic Valve Replacement Surgery
1 other identifier
interventional
4
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 18, 2016
CompletedFirst Posted
Study publicly available on registry
February 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedApril 4, 2018
April 1, 2018
1.8 years
February 18, 2016
April 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Neuropsychological assesment
Investigators will use a neuropsychological test battery to test our subject pre- and post-operatively. A qualified psychologist will administer the test battery. The test battery will be relatively simple but still have several different tests. These tests will include but are not limited to: \- Trail Making test A \& B (TMT)
1 month postoperatively
Neuropsychological assesment
Digit Span test
1 month postoperatively
Neuropsychological assesment
Rey Auditory Verbal Learning Test (RAVLT)
1 month postoperatively
Secondary Outcomes (2)
Inflammation markers analysed from plasma and tissue samples
A day before surgery, during surgery, 24hour and 48hour postoperatively
Tissue specific markers analysed from plasma
A day before surgery, during surgery, 24hour and 48hour postoperatively
Study Arms (2)
Remote ischemic preconditioning
EXPERIMENTALPatient will undergo normal isolated aortic valve replacement surgery with a biological prosthesis and a preoperative lower leg remote ischemic preconditioning(RIPC) phase.
Control group
NO INTERVENTIONPatient will undergo normal isolated aortic valve replacement surgery with a biological prosthesis
Interventions
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.
Eligibility Criteria
You may qualify if:
- Non-emergency aortic valve replacement with a biological prosthesis with perfusion and cardiac arrest
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oulu University Hospital, Department of Cardiothoracic surgery
Oulu, 900220, Finland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Fredrik Yannopoulos, MD Ph.D
Oulu University Hospital
- STUDY CHAIR
Vesa Anttila, MD Ph.D.
Oulu University Hospital
- PRINCIPAL INVESTIGATOR
Tuomas Ahvenvaara, MD
Oulu University Hospital
- PRINCIPAL INVESTIGATOR
Tuomas Mäkelä, MD.Ph.D.
Oulu University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident
Study Record Dates
First Submitted
February 18, 2016
First Posted
February 29, 2016
Study Start
February 1, 2016
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
April 4, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share