Myocardial Ischemia Clinical Trial
Official title:
Remote Ischemic Preconditioning in Patients Undergoing Isolated Aortic Valve Replacement Surgery With a Biological Prosthesis: A Single Center Randomized Prospective Study
Verified date | April 2018 |
Source | Oulu University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 4 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Finland | Oulu University Hospital, Department of Cardiothoracic surgery | Oulu |
Lead Sponsor | Collaborator |
---|---|
Oulu University Hospital |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Neuropsychological assesment | Digit Span test | 1 month postoperatively | |
Primary | Neuropsychological assesment | Rey Auditory Verbal Learning Test (RAVLT) | 1 month postoperatively | |
Secondary | Inflammation markers analysed from plasma and tissue samples | 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. |
A day before surgery, during surgery, 24hour and 48hour postoperatively | |
Secondary | Tissue specific markers analysed from plasma | 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 |
A day before surgery, during surgery, 24hour and 48hour postoperatively |
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