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NCT Number: NCT07048002

Interventions for Silent Brain Infarction and Perioperative Neurocognitive Disorders in Cardiovascular Surgery

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.

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Key information

Conditions

Silent Brain Infarction Cardiac Surgery Mental Disorders Neurocognitive Disorders Neuroprotective

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Chaoyang Hospital，Capital Medical University, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Managements for NeuroFirst target bundle

Other

In the intervention group, patient management aims to achieve the NeuroFirst target bundle, including 1) mean arterial pressure (MAP) 65-90 mmHg, 2) bispectral index (BIS) 40-60, 3) regional cerebral oxygen saturation (rSO2)≥ 60% , and 4) arterial inflow temperature <37 ℃ and rewarming rate < 0.5 ℃/min after exceeding 30℃ during CPB.

To achieve this target bundle, pharmacologic agents, fluid resuscitation, blood transfusion, and other therapeutic modalities will be utilized. These interventions are guided by comprehensive intraoperative monitoring, including conventional hemodynamic monitoring, invasive or non-invasive cardiac output and vascular resistance assessments.

Managements for institutional routine

Other

MAP, BIS, cerebral rSO2 and arterial inflow temperature during CPB rewarming, will be managed according to institutional routine in accordance with published guidelines.

Primary outcomes

  1. the 7-day incidence of new-onset silent brain infarction (SBI)

    Time frame: within 7 days postoperatively

    New-onset silent brain infarction refers to newly developed cerebral infarctions detected on MRI, compared with the preoperative MRI, in the absence of any corresponding clinical symptoms of cerebral infarction.

Secondary outcomes

  1. Key Secondary Outcome: the 30-day incidence of perioperative neurocognitive disorders (PND)

    Time frame: within 30 days postoperatively

    The incidence of 30-day PND includes the incidence of postoperative delirium in hospital and perioperative neurocognitive disorders within 30 days after surgery

  2. the 5-day incidence of postoperative delirium

    Time frame: within five days postoperatively

    the incedence of delirium evaluated by CAM/CAM-ICU

  3. the 30-day incidence of new-onset overt stroke

    Time frame: within 30 days postoperatively

    Postoperative new-onset overt stroke was defined as any new ischemic or hemorrhagic cerebrovascular event after surgery with focal or global neurological (motor, sensory or cognitive) dysfunction lasting at least 24 h. And a broadened stroke definition also including neurological dysfunction of <24 h duration with corresponding evidence of central nervous system hemorrhage or infarction (including pathological, imaging, or other objective evidence of cerebral, spinal cord or retinal focal ischemic injury in a defined vascular distribution).

  4. the 1-year incidence of new-onset overt stroke

    Time frame: within 1 year postoperatively

    Postoperative new-onset overt stroke was defined as any new ischemic or hemorrhagic cerebrovascular event after surgery with focal or global neurological (motor, sensory or cognitive) dysfunction lasting at least 24 h. And a broadened stroke definition also including neurological dysfunction of <24 h duration with corresponding evidence of central nervous system hemorrhage or infarction (including pathological, imaging, or other objective evidence of cerebral, spinal cord or retinal focal ischemic injury in a defined vascular distribution).

  5. the 1-year incidence of perioperative neurocognitive disorders (PND)

    Time frame: within 1 year postoperatively

    the incidence of perioperative neurocognitive disorders (PND)

  6. the 30-day composite incidence of major adverse events

    Time frame: within 30 days postoperatively

    Major adverse events refer to renal insufficiency, myocardial infarction, pulmonary embolism, seizure and all-cause mortality.

  7. the 1-year composite incidence of major adverse events

    Time frame: within 1 year postoperatively

    Major adverse events refer to renal insufficiency, myocardial infarction, pulmonary embolism, seizure and all-cause mortality.

  8. the 30-day incidence of transient ischemic attack (TIA)

    Time frame: within 30 days postoperatively

    TIA is defined as focal arterial ischemia with transient symptoms (lasting <24 hours) and without evidence of infarction by pathology or imaging.

  9. the 1-year incidence of transient ischemic attack (TIA)

    Time frame: within 1 year postoperatively

    TIA is defined as focal arterial ischemia with transient symptoms (lasting <24 hours) and without evidence of infarction by pathology or imaging.

Other outcomes

  1. Length of stay (LOS) in intensive care unit (ICU)

    Time frame: Perioperative

    Length of stay (LOS) in intensive care unit (ICU) postoperatively

  2. Length of stay (LOS) in hospital

    Time frame: Perioperative

    Length of stay (LOS) in hospital postoperatively

  3. Hospitalization cost

    Time frame: Perioperative

    Operative and postoperative hospitalization cost

Study contacts

Contact information is provided by the study sponsor or research team.

Jia Shi, M.D.

CONTACT

[email protected]

+86 10 88322467

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Other

Registry information

Official study title

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

Acronym: INSPIRE

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jul 2, 2025
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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