Dynamics of microRNA Expression and Systemic Inflammatory Response in POCD After Cardiac Surgery (NCT07231731) | Clinical Trial Compass
CompletedNot Applicable
Dynamics of microRNA Expression and Systemic Inflammatory Response in POCD After Cardiac Surgery
Croatia48 participantsStarted 2022-05-31
Plain-language summary
Postoperative cognitive decline (POCD) is one of the most common complications after cardiac surgery. It is characterized by impaired memory, attention, and executive functions and can have long-term consequences. The goal of this observational study was to investigate the mechanisms of cognitive decline after cardiac surgery and potential biomarkers that could aid in the diagnosis, prevention, and treatment of POCD. The investigators focused on the role of microRNAs (miRNAs) and systemic inflammatory response to surgery, extracorporeal circulation, and anesthesia as potential factors involved in the development of the neuroinflammatory response and subsequent POCD. The main question this study aims to answer is whether perioperative miRNA 151-5p expression is associated with POCD after surgery. The second aim is to examine the association between miRNA-151-5p and systemic inflammation. The investigators measured circulating miRNA-151-5p levels and plasma levels of inflammatory biomarkers in patients undergoing surgical myocardial revascularization. To assess cognitive function, participants completed the Montreal Cognitive Assessment (MoCA Test). Changes in the measured values of miRNA-151-5p expression and inflammatory markers, as well as changes in cognitive status after surgery, were assessed in relation to the preoperative state.
Who can participate
Age range
65 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* patients undergoing coronary artery bypass graft surgery to treat coronary artery disease
* two or more coronary bypass surgery with the use of extracorporeal circulation
* patients between the ages of 65 and 80
* patients according to the classification of the American Society of Anesthesiologists (ASA) classified in groups III and IV
* patients who agreed to participate in the research and signed an informed consent
Exclusion Criteria:
* patients with communication difficulties (severe visual, hearing and speech impairment)
* illiterate patients
* patients with a history of dementia, schizophrenia, Parkinson's disease, Alzheimer's disease, alcoholism
* patients with previously known liver failure of any grade according to the Child-Pough classification
* patients with previously known renal failure greater than grade 2
* patients taking immunosuppressive, corticosteroid and anticholinergic therapy
* intraoperatively used cell-saver and/or hemofilter
* patients in whom the planned procedure is not performed
* patients in whom it is not possible to assess cognitive functions postoperatively (patients sedated due to intra- or postoperative surgical complications)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Perioperative changes in microRNA 151-5p expression.
Timeframe: Preoperative, within 2 hours of ICU admission, 48 hours after ICU admission
2
Perioperative changes in cognitive function measured by Montreal Cognitive Assessment (MoCA Test).
Timeframe: 1 day before surgery and once daily postoperatively, up to the 6th postoperative day.