Actively Recruiting
Interventions for Silent Brain Infarction and Perioperative Neurocognitive Disorders in Cardiovascular Surgery
Led by Chinese Academy of Medical Sciences, Fuwai Hospital · Updated on 2025-11-24
912
Participants Needed
5
Research Sites
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Interventions for Silent Brain Infarction and Perioperative Neurocognitive Disorders in Cardiovascular Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female adult patients aged 60 years or older
- Receiving elective cardiovascular surgery with cardiopulmonary bypass
- Written Informed consent provided
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Beijing Chaoyang Hospital，Capital Medical University
Beijing, Beijing Municipality, China, 100020
Actively Recruiting
2
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, 100037
Actively Recruiting
3
Xuanwu Hospital,Capital Medical University
Beijing, Beijing Municipality, China, 100053
Actively Recruiting
4
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100160
Actively Recruiting
5
The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430014
Actively Recruiting
Research Team
J
Jia Shi, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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