Silent Brain InfarctionINSPIRENCT07048002
Interventions for Silent Brain Infarction and Perioperative Neurocognitive Disorders in Cardiovascular Surgery
A study testing Managements for NeuroFirst target bundle and Managements for institutional routine in people with Silent Brain Infarction and Neurocognitive Disorders, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 5 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Silent Brain Infarction, Neurocognitive Disorders, Cardiac Surgery
- What is being tested?
- Managements for NeuroFirst target bundle and Managements for institutional routine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 912 participants
- Where
- 5 sitesChina
- Study dates
- 6 Jul 2025to 31 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female adult patients aged 60 years or older
- Receiving elective cardiovascular surgery with cardiopulmonary bypass
- Written Informed consent provided
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Beijing Chaoyang Hospital，Capital Medical University
Beijing, Beijing Municipality, 100020
Changwei Wei, M.D., 8610 85231330, wcw0025@sina.com
Changwei Wei, M.D.
- 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, 100037
Jia Shi, M.D., 86 10 88322467, shijia@fuwai.com
Jia Shi, M.D.
- Recruiting
Xuanwu Hospital,Capital Medical University
Beijing, Beijing Municipality, 100053
Lei Zhao, M.D., 86 10 83199352, zhaoalei@sina.com
Lei Zhao, M.D.
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100160
Shu Li, M.D., 86 10 59976658, lishu@bjtth.org
Shu Li, M.D.
- Recruiting
The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430014
Jingli Chen, M.D., 8610 82811446, chenjinli2001@sina.com
Jingli Chen, M.D.
About this study
Official title: Interventions for Silent Brain Infarction and Perioperative Neurocognitive Disorders in Cardiovascular Surgery (the INSPIRE Study)
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.
Read more
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.
- Being tested
- Managements for NeuroFirst target bundle, Managements for institutional routine
- Medical subject headings
- Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Managements for NeuroFirst target bundleOther
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 routineOther
MAP, BIS, cerebral rSO2 and arterial inflow temperature during CPB rewarming, will be managed according to institutional routine in accordance with published guidelines.
| Study group | Role | What they receive |
|---|---|---|
| NeuroFirst target bundle | Experimental | Management for NeuroFirst target bundle Receives: Other: Managements for NeuroFirst target bundle |
| Routine Management | Active comparator | Management for institutional routine in accordance with published guidelines Receives: Other: Managements for institutional routine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the 7-day incidence of new-onset silent brain infarction (SBI)
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.
Measured: within 7 days postoperatively
Secondary outcomes (9)
Key Secondary Outcome: the 30-day incidence of perioperative neurocognitive disorders (PND)
The incidence of 30-day PND includes the incidence of postoperative delirium in hospital and perioperative neurocognitive disorders within 30 days after surgery
Measured: within 30 days postoperatively
the 5-day incidence of postoperative delirium
the incedence of delirium evaluated by CAM/CAM-ICU
Measured: within five days postoperatively
the 30-day incidence of new-onset overt stroke
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).
Measured: within 30 days postoperatively
the 1-year incidence of new-onset overt stroke
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).
Measured: within 1 year postoperatively
the 1-year incidence of perioperative neurocognitive disorders (PND)
the incidence of perioperative neurocognitive disorders (PND)
Measured: within 1 year postoperatively
the 30-day composite incidence of major adverse events
Major adverse events refer to renal insufficiency, myocardial infarction, pulmonary embolism, seizure and all-cause mortality.
Measured: within 30 days postoperatively
the 1-year composite incidence of major adverse events
Major adverse events refer to renal insufficiency, myocardial infarction, pulmonary embolism, seizure and all-cause mortality.
Measured: within 1 year postoperatively
the 30-day incidence of transient ischemic attack (TIA)
TIA is defined as focal arterial ischemia with transient symptoms (lasting <24 hours) and without evidence of infarction by pathology or imaging.
Measured: within 30 days postoperatively
the 1-year incidence of transient ischemic attack (TIA)
TIA is defined as focal arterial ischemia with transient symptoms (lasting <24 hours) and without evidence of infarction by pathology or imaging.
Measured: within 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start6 Jul 2025
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Silent Brain InfarctionStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 912 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SHI Jia, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048002
- Sponsor's protocol ID
- The INSPIRE study
- Acronym
- INSPIRE
- Status last verified
- Jul 2025
- First submitted
- 12 Jun 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared in order to protect participant privacy and confidentiality. Additionally, the consent obtained from participants does not include provisions for data sharing, in accordance with ethical guidelines and institutional policies.
Publications
Uysal S, Lin HM, Trinh M, Park CH, Reich DL. Optimizing cerebral oxygenation in cardiac surgery: A randomized controlled trial examining neurocognitive and perioperative outcomes. J Thorac Cardiovasc Surg. 2020 Mar;159(3):943-953.e3. doi: 10.1016/j.jtcvs.2019.03.036. Epub 2019 Mar 29.
PubMed 31056357Maheshwari A, McCormick PJ, Sessler DI, Reich DL, You J, Mascha EJ, Castillo JG, Levin MA, Duncan AE. Prolonged concurrent hypotension and low bispectral index ('double low') are associated with mortality, serious complications, and prolonged hospitalization after cardiac surgery. Br J Anaesth. 2017 Jul 1;119(1):40-49. doi: 10.1093/bja/aex095.
PubMed 28974062Descamps R, Amour J, Besnier E, Bougle A, Charbonneau H, Charvin M, Cholley B, Desebbe O, Fellahi JL, Frasca D, Labaste F, Lena D, Mahjoub Y, Mertes PM, Molliex S, Moury PH, Moussa MD, Oilleau JF, Ouattara A, Provenchere S, Rozec B, Parienti JJ, Fischer MO; OPTIPAM investigators. Perioperative individualized hemodynamic optimization according to baseline mean arterial pressure in cardiac surgery patients: Rationale and design of the OPTIPAM randomized trial. Am Heart J. 2023 Jul;261:10-20. doi: 10.1016/j.ahj.2023.03.005. Epub 2023 Mar 18.
PubMed 36934980Gerstenecker A, Norling AM, Jacob A, Lazar RM. Silent Brain Infarction, Delirium, and Cognition in Three Invasive Cardiovascular Procedures: a Systematic Review. Neuropsychol Rev. 2023 Jun;33(2):474-491. doi: 10.1007/s11065-022-09548-1. Epub 2022 Jul 8.
PubMed 35804216Newman MF, Kirchner JL, Phillips-Bute B, Gaver V, Grocott H, Jones RH, Mark DB, Reves JG, Blumenthal JA; Neurological Outcome Research Group and the Cardiothoracic Anesthesiology Research Endeavors Investigators. Longitudinal assessment of neurocognitive function after coronary-artery bypass surgery. N Engl J Med. 2001 Feb 8;344(6):395-402. doi: 10.1056/NEJM200102083440601.
PubMed 11172175Brown CH 4th, Probert J, Healy R, Parish M, Nomura Y, Yamaguchi A, Tian J, Zehr K, Mandal K, Kamath V, Neufeld KJ, Hogue CW. Cognitive Decline after Delirium in Patients Undergoing Cardiac Surgery. Anesthesiology. 2018 Sep;129(3):406-416. doi: 10.1097/ALN.0000000000002253.
PubMed 29771710Cheng C, Wan H, Cong P, Huang X, Wu T, He M, Zhang Q, Xiong L, Tian L. Targeting neuroinflammation as a preventive and therapeutic approach for perioperative neurocognitive disorders. J Neuroinflammation. 2022 Dec 12;19(1):297. doi: 10.1186/s12974-022-02656-y.
PubMed 36503642Indja B, Woldendorp K, Vallely MP, Grieve SM. Silent Brain Infarcts Following Cardiac Procedures: A Systematic Review and Meta-Analysis. J Am Heart Assoc. 2019 May 7;8(9):e010920. doi: 10.1161/JAHA.118.010920.
PubMed 31017035Vermeer SE, Prins ND, den Heijer T, Hofman A, Koudstaal PJ, Breteler MM. Silent brain infarcts and the risk of dementia and cognitive decline. N Engl J Med. 2003 Mar 27;348(13):1215-22. doi: 10.1056/NEJMoa022066.
PubMed 12660385Fanning JP, Wong AA, Fraser JF. The epidemiology of silent brain infarction: a systematic review of population-based cohorts. BMC Med. 2014 Jul 9;12:119. doi: 10.1186/s12916-014-0119-0.
PubMed 25012298Sultan I, Bianco V, Kilic A, Jovin T, Jadhav A, Jankowitz B, Aranda-Michel E, D'angelo MP, Navid F, Wang Y, Thoma F, Gleason TG. Predictors and Outcomes of Ischemic Stroke After Cardiac Surgery. Ann Thorac Surg. 2020 Aug;110(2):448-456. doi: 10.1016/j.athoracsur.2020.02.025. Epub 2020 Mar 19.
PubMed 32199830Wang L, Li S, Devereaux PJ, Lv H, Li T, Zhang L, An Y, Chen J, Wei C, Zhao L, Peng Y, Shi J. Interventions for Silent Brain Infarction and Perioperative Neurocognitive Disorders in Cardiovascular Surgery (INSPIRE): study protocol for a multicentre randomised controlled trial. BMJ Open. 2026 Jun 19;16(6):e116246. doi: 10.1136/bmjopen-2026-116246.
PubMed 42320960
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventions for Silent Brain Infarction and Perioperative Neurocognitive Disorders in Cardiovascular Surgery (the INSPIRE Study)
- ClinicalTrials.gov ID
- NCT07048002
- Acronym / sponsor ID
- INSPIRE / The INSPIRE study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 912 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 6 Jul 2025 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 2 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NeuroFirst target bundle | Experimental | Other: Managements for NeuroFirst target bundleManagement for NeuroFirst target bundle |
| Routine Management | Active comparator | Other: Managements for institutional routineManagement for institutional routine in accordance with published guidelines |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female adult patients aged 60 years or older
- Receiving elective cardiovascular surgery with cardiopulmonary bypass
- Written Informed consent provided
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Managements for NeuroFirst target bundleIn 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. | Other | NeuroFirst target bundle |
| Managements for institutional routineMAP, BIS, cerebral rSO2 and arterial inflow temperature during CPB rewarming, will be managed according to institutional routine in accordance with published guidelines. | Other | Routine Management |
Primary outcome
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.
9 secondary outcomes
Key Secondary Outcome: the 30-day incidence of perioperative neurocognitive disorders (PND)
Time frame: within 30 days postoperatively
the 5-day incidence of postoperative delirium
Time frame: within five days postoperatively
the 30-day incidence of new-onset overt stroke
Time frame: within 30 days postoperatively
the 1-year incidence of new-onset overt stroke
Time frame: within 1 year postoperatively
the 1-year incidence of perioperative neurocognitive disorders (PND)
Time frame: within 1 year postoperatively
the 30-day composite incidence of major adverse events
Time frame: within 30 days postoperatively
the 1-year composite incidence of major adverse events
Time frame: within 1 year postoperatively
the 30-day incidence of transient ischemic attack (TIA)
Time frame: within 30 days postoperatively
the 1-year incidence of transient ischemic attack (TIA)
Time frame: within 1 year postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Background: PubMed 31056357Uysal S, Lin HM, Trinh M, Park CH, Reich DL. Optimizing cerebral oxygenation in cardiac surgery: A randomized controlled trial examining neurocognitive and perioperative outcomes. J Thorac Cardiovasc Surg. 2020 Mar;159(3):943-953.e3. doi: 10.1016/j.jtcvs.2019.03.036. Epub 2019 Mar 29.
- Background: PubMed 28974062Maheshwari A, McCormick PJ, Sessler DI, Reich DL, You J, Mascha EJ, Castillo JG, Levin MA, Duncan AE. Prolonged concurrent hypotension and low bispectral index ('double low') are associated with mortality, serious complications, and prolonged hospitalization after cardiac surgery. Br J Anaesth. 2017 Jul 1;119(1):40-49. doi: 10.1093/bja/aex095.
- Background: PubMed 36934980Descamps R, Amour J, Besnier E, Bougle A, Charbonneau H, Charvin M, Cholley B, Desebbe O, Fellahi JL, Frasca D, Labaste F, Lena D, Mahjoub Y, Mertes PM, Molliex S, Moury PH, Moussa MD, Oilleau JF, Ouattara A, Provenchere S, Rozec B, Parienti JJ, Fischer MO; OPTIPAM investigators. Perioperative individualized hemodynamic optimization according to baseline mean arterial pressure in cardiac surgery patients: Rationale and design of the OPTIPAM randomized trial. Am Heart J. 2023 Jul;261:10-20. doi: 10.1016/j.ahj.2023.03.005. Epub 2023 Mar 18.
- Background: PubMed 35804216Gerstenecker A, Norling AM, Jacob A, Lazar RM. Silent Brain Infarction, Delirium, and Cognition in Three Invasive Cardiovascular Procedures: a Systematic Review. Neuropsychol Rev. 2023 Jun;33(2):474-491. doi: 10.1007/s11065-022-09548-1. Epub 2022 Jul 8.
- Background: PubMed 11172175Newman MF, Kirchner JL, Phillips-Bute B, Gaver V, Grocott H, Jones RH, Mark DB, Reves JG, Blumenthal JA; Neurological Outcome Research Group and the Cardiothoracic Anesthesiology Research Endeavors Investigators. Longitudinal assessment of neurocognitive function after coronary-artery bypass surgery. N Engl J Med. 2001 Feb 8;344(6):395-402. doi: 10.1056/NEJM200102083440601.
- Background: PubMed 29771710Brown CH 4th, Probert J, Healy R, Parish M, Nomura Y, Yamaguchi A, Tian J, Zehr K, Mandal K, Kamath V, Neufeld KJ, Hogue CW. Cognitive Decline after Delirium in Patients Undergoing Cardiac Surgery. Anesthesiology. 2018 Sep;129(3):406-416. doi: 10.1097/ALN.0000000000002253.
- Background: PubMed 36503642Cheng C, Wan H, Cong P, Huang X, Wu T, He M, Zhang Q, Xiong L, Tian L. Targeting neuroinflammation as a preventive and therapeutic approach for perioperative neurocognitive disorders. J Neuroinflammation. 2022 Dec 12;19(1):297. doi: 10.1186/s12974-022-02656-y.
- Background: PubMed 31017035Indja B, Woldendorp K, Vallely MP, Grieve SM. Silent Brain Infarcts Following Cardiac Procedures: A Systematic Review and Meta-Analysis. J Am Heart Assoc. 2019 May 7;8(9):e010920. doi: 10.1161/JAHA.118.010920.
- Background: PubMed 12660385Vermeer SE, Prins ND, den Heijer T, Hofman A, Koudstaal PJ, Breteler MM. Silent brain infarcts and the risk of dementia and cognitive decline. N Engl J Med. 2003 Mar 27;348(13):1215-22. doi: 10.1056/NEJMoa022066.
- Background: PubMed 25012298Fanning JP, Wong AA, Fraser JF. The epidemiology of silent brain infarction: a systematic review of population-based cohorts. BMC Med. 2014 Jul 9;12:119. doi: 10.1186/s12916-014-0119-0.
- Background: PubMed 32199830Sultan I, Bianco V, Kilic A, Jovin T, Jadhav A, Jankowitz B, Aranda-Michel E, D'angelo MP, Navid F, Wang Y, Thoma F, Gleason TG. Predictors and Outcomes of Ischemic Stroke After Cardiac Surgery. Ann Thorac Surg. 2020 Aug;110(2):448-456. doi: 10.1016/j.athoracsur.2020.02.025. Epub 2020 Mar 19.
- Derived from this study: PubMed 42320960Wang L, Li S, Devereaux PJ, Lv H, Li T, Zhang L, An Y, Chen J, Wei C, Zhao L, Peng Y, Shi J. Interventions for Silent Brain Infarction and Perioperative Neurocognitive Disorders in Cardiovascular Surgery (INSPIRE): study protocol for a multicentre randomised controlled trial. BMJ Open. 2026 Jun 19;16(6):e116246. doi: 10.1136/bmjopen-2026-116246.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared in order to protect participant privacy and confidentiality. Additionally, the consent obtained from participants does not include provisions for data sharing, in accordance with ethical guidelines and institutional policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Managements for NeuroFirst target bundle and Managements for institutional routine in people with Silent Brain Infarction and Neurocognitive Disorders, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jia Shi, M.D. (+86 10 88322467, shijia@fuwai.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the 7-day incidence of new-onset silent brain infarction (SBI) (time frame: within 7 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07048002, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.