NeuroFirst brain protection for adults having heart bypass surgery
Interventions for Silent Brain Infarction and Perioperative Neurocognitive Disorders in Cardiovascular Surgery (the INSPIRE Study)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 912 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Chinese Academy of Medical Sciences, Fuwai Hospital Academic / other |
| Locations | 5 sites (Beijing, Beijing Municipality and 4 other locations) |
| Trial ID | NCT07048002 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Beijing, Beijing Municipality and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.