Interventions for Silent Brain Infarction and Perioperative Neurocognitive Dysfunction in Cardiovascular Surgery (the INSPIRE Study)

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• Male or female adult patients aged 60 years or older

• Receiving elective cardiovascular surgery with cardiopulmonary bypass

• Written Informed consent provided

Locations
Other Locations
China
Beijing Tiantan Hospital, Capital Medical University
RECRUITING
Beijing
State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College
RECRUITING
Beijing
Xuanwu Hospital,Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Jia Shi, M.D.
shijia@fuwai.com
+86 10 88322467
Time Frame
Start Date: 2025-07-06
Estimated Completion Date: 2028-10-31
Participants
Target number of participants: 912
Treatments
Experimental: NeuroFirst target bundle
Management for NeuroFirst target bundle
Active_comparator: Routine Management
Management for institutional routine in accordance with published guidelines
Related Therapeutic Areas
Sponsors
Leads: Chinese Academy of Medical Sciences, Fuwai Hospital

This content was sourced from clinicaltrials.gov