Neurological Outcome After Minimal Invasive Coronary Artery Bypass Graft
Belgium180 participantsStarted 2016-12
Plain-language summary
Primary objectives:
Assessment of the incidence of postoperative cognitive dysfunction (POCD), cerebrovascular accident (CVA), and delirium after minimal invasive coronary artery bypass grafting (Endo-CABG).
Secondary objectives:
* Quality of life, three months after endo-CABG
* Patient satisfaction with endo-CABG and the tests performed
* The influence of various demographic and peri-operative variables on neurological outcome after endo-CABG
* Incidence of fear and depression, 3 months after endo-CABG
Who can participate
Age range
18 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:
* Minimum age of 18
* Elective Endo-CABG procedure (group 1)
* Elective PCI procedure (group 2)
* Elective healthy volunteer
Exclusion Criteria:
* Medical history of:
* Postoperative cognitive dysfunction, delirium or cerebrovascular accident
* symptomatic carotid artery disease
* Dementia
* Renal dysfunction: glomular filtration rate (GFR) \< 30 ml/min
* Hepatic dysfunction: serum glutamic-oxaloacetic transaminase (SGOT)/ aspartate aminotransferase (AST), or serum glutamic-pyruvic transaminase (SGPT)/ alanine aminotransferase (ALT), more than three timer higher than normal limits
* History of medication and alcohol abuse
* Language barrier or incapability to communicate
* Physical condition making participation impossible
* Participation in other clinical trials of a drug or medical instrument
* Surgical revision or intra-operative major cardial event (Endo-CABG group)
* Conversion to cardiac surgery or intra-operative major event (PCI group)
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.