NCT07048002 Interventions for Silent Brain Infarction and Perioperative Neurocognitive Disorders in Cardiovascular Surgery
| NCT ID | NCT07048002 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese Academy of Medical Sciences, Fuwai Hospital |
| Condition | Silent Brain Infarction |
| Study Type | INTERVENTIONAL |
| Enrollment | 912 participants |
| Start Date | 2025-07-06 |
| Primary Completion | 2027-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 912 participants in total. It began in 2025-07-06 with a primary completion date of 2027-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07048002 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Silent Brain Infarction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07048002 currently recruiting?
Yes, NCT07048002 is actively recruiting participants. Contact the research team at shijia@fuwai.com for enrollment information.
Where is the NCT07048002 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China, Beijing, China, Beijing, China and 1 additional location.
Who is sponsoring the NCT07048002 clinical trial?
NCT07048002 is sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital. The trial plans to enroll 912 participants.