Interventions for Silent Brain Infarction and Perioperative Neurocognitive Disorders in Cardiovas… (NCT07048002) | Clinical Trial Compass
RecruitingNot Applicable
Interventions for Silent Brain Infarction and Perioperative Neurocognitive Disorders in Cardiovascular Surgery
China912 participantsStarted 2025-07-06
Plain-language summary
the purpose of the study is to investigate whether a combined anesthetic targets bundle, known as the NeuroFirst strategy, focused on neurological protection, can reduce the incidence of silent brain infarction (SBI) and perioperative neurocognitive disorders (PND) in patients undergoing cardiac surgery. Additionally, the trial will assess the safety of this strategy.
The NeuroFirst target bundle incorporates multiple parameters, including mean arterial pressure (MAP), bispectral index (BIS), regional cerebral oxygen saturation (rSO2), and arterial inflow temperature during cardiopulmonary bypass.
The primary question this study seeks to answer is: Does the NeuroFirst strategy reduce the incidence of SBI and PND in cardiac surgery?
To address this, researchers will compare the NeuroFirst strategy with routine institutional practices based on published guidelines. Participants will be randomly assigned to either the NeuroFirst group or the routine care group. All participants will undergo magnetic resonance imaging (MRI), be assessed using the Confusion Assessment Method (CAM) and the Montreal Cognitive Assessment (MoCA), and be followed for up to one year postoperatively.
Who can participate
Age range
60 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:
* Male or female adult patients aged 60 years or older
* Receiving elective cardiovascular surgery with cardiopulmonary bypass
* Written Informed consent provided
Exclusion criteria:
* Contraindication to MRI scanning
* Not suitable for receiving interventions to achieve NeuroFirst target bundle
* Unable to receive neuro-cognitive evaluation due to language, vision, or hearing impairments
* Breastfeeding or pregnancy
* Terminal illness with a life expectancy of less than 3 months
* Mental or legal disability
* current enrollment in other interventional study
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
the 7-day incidence of new-onset silent brain infarction (SBI)
Timeframe: within 7 days postoperatively
Trial details
NCT IDNCT07048002
SponsorChinese Academy of Medical Sciences, Fuwai Hospital