NeuroFirst brain protection for adults having heart bypass surgery
Official title: Interventions for Silent Brain Infarction and Perioperative Neurocognitive Disorders in Cardiovascular Surgery (the INSPIRE Study)
Run by Chinese Academy of Medical Sciences, Fuwai Hospital · NCT07048002 · Data updated 2026-11-12
This trial tests whether a bundled anesthesia approach called NeuroFirst can help people aged 60 and older having planned heart surgery with cardiopulmonary bypass avoid silent brain infarcts and thinking or memory problems after surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 60 Years and up |
| Sex | All |
| Enrollment | 912 (estimated) |
| Sponsor | Chinese Academy of Medical Sciences, Fuwai Hospital Academic / other |
| Locations | 5 sites (Beijing, Beijing Municipality and 4 other locations) |
| Status | Recruiting |
| Started | July 6, 2025 |
| Main results expected | October 31, 2027 |
| Study ends | October 31, 2028 |
| Registry record updated | November 24, 2025 |
| Trial ID | NCT07048002 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 60 or older scheduled for elective cardiovascular surgery with cardiopulmonary bypass who can undergo MRI and complete neurocognitive testing.
✕Probably not a fit
Patients who cannot have MRI, cannot comply with cognitive testing, are unsuitable for the NeuroFirst interventions, or have a very limited life expectancy are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults 60 years and older undergoing elective cardiovascular surgery with cardiopulmonary bypass are randomly assigned to a NeuroFirst targeted anesthetic bundle or to routine institutional care. The NeuroFirst bundle sets targets for mean arterial pressure (MAP), depth of anesthesia (BIS), regional cerebral oxygen saturation (rSO2), and arterial inflow temperature during bypass. Outcomes include incidence of silent brain infarction on MRI, perioperative neurocognitive disorder measured by cognitive testing, and safety/adverse events. Results between the two groups will be compared to see if the targeted bundle reduces neurologic injury without increasing harms.
Why it matters
Potential benefit: If successful, NeuroFirst could reduce unrecognized brain infarcts and postoperative thinking or memory problems after heart surgery.
How similar studies have gone: Previous studies of individual components like blood pressure management, cerebral oxygen monitoring, and anesthetic depth have shown mixed but promising results, while the bundled NeuroFirst approach is relatively new and less well established.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Beijing Chaoyang Hospital，Capital Medical University
Beijing, Beijing Municipality, China Recruiting -
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 Recruiting -
Xuanwu Hospital,Capital Medical University
Beijing, Beijing Municipality, China Recruiting -
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China Recruiting -
The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China Recruiting
Study contacts
- Study coordinator: Jia Shi, M.D.
- Email: shijia@fuwai.com
- Phone: +86 10 88322467
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.