Clinical trial NCT02694016: Remote Ischemic Preconditioning in Patients Undergoing Isolated Aortic Valve Replacement Surgery
Official title: Remote Ischemic Preconditioning in Patients Undergoing Isolated Aortic Valve Replacement Surgery With a Biological Prosthesis: A Single Center Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Aortic Valve Disease
Myocardial Ischemia
Keywords: Remote ischemic preconditioning
Neuroprotection
Lead sponsor: Oulu University Hospital
Sponsor class: OTHER
First posted: 2016-02-29
Enrollment: 4
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Neuropsychological assesment
timeFrame: 1 month postoperatively
measure: Neuropsychological assesment
timeFrame: 1 month postoperatively
measure: Neuropsychological assesment
timeFrame: 1 month postoperatively
Secondary outcomes:
measure: Inflammation markers analysed from plasma and tissue samples
timeFrame: A day before surgery, during surgery, 24hour and 48hour postoperatively
measure: Tissue specific markers analysed from plasma
timeFrame: A day before surgery, during surgery, 24hour and 48hour postoperatively
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital, Department of Cardiothoracic surgery
Study officials:
affiliation: Oulu University Hospital
name: Fredrik Yannopoulos, MD Ph.D
role: STUDY_DIRECTOR
affiliation: Oulu University Hospital
name: Vesa Anttila, MD Ph.D.
role: STUDY_CHAIR
affiliation: Oulu University Hospital
name: Tuomas Ahvenvaara, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oulu University Hospital
name: Tuomas Mäkelä, MD.Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: