Interventions for Silent Brain Infarction and Perioperative Neurocognitive Disorders in Cardiovascular Surgery
Recruiting now · Not applicable
Conditions studied: Silent Brain Infarction, Neurocognitive Disorders, Cardiac Surgery, Neuroprotective
In brief
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.
Key facts
- Study ID
- NCT07048002
- Run by
- Chinese Academy of Medical Sciences, Fuwai Hospital
- People needed
- 912
- Starts
- 2025-07-06
- Expected to finish
- 2028-10-31
- Last updated by the study team
- 2025-11-24
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female adult patients aged 60 years or older
- Receiving elective cardiovascular surgery with cardiopulmonary bypass
- Written Informed consent provided
You may not qualify if…
- 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
Where it is running
- Beijing Chaoyang Hospital，Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
- State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College — Beijing, Beijing Municipality, China (enrolling)
- Xuanwu Hospital,Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
- Beijing Tiantan Hospital, Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
- The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (enrolling)
Full record on ClinicalTrials.gov
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