Cardiac SurgeryPEACENCT06660602
Perioperative Cerebral Function Assessment for Cardiac Surgery
An observational study of Cardiac Surgery, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
Perioperative neurological complications in cardiovascular surgical procedures are associated with a significant risk of mortality and disability. This study is aimed at identifying the specific risk factors associated with these neurological complications during the perioperation and developing a comprehensive… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- cardiac surgery
- Type of treatment
- Surgery or procedure
- How many people
- 1,845 participants
- Where
- 1 siteChina
- Study dates
- 8 Feb 2025to Jul 2028
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent cardiac surgeries
Who may be able to join
- Age 18-80 years;
- Patients undergoing cardiovascular surgical procedures;
- Able to understand and comply with the clinical trial protocol requirements, and willing to sign the informed consent form.
Who cannot join
- Inability to tolerate required diagnostic procedures, including neck CT angiography (CTA), head CT perfusion (CTP), or electroencephalography (EEG), due to underlying physical limitations or medical contraindications;
- Severe renal insufficiency, characterized by a creatinine clearance of less than 30 mL/min (using the Cockcroft-Gault formula), serum creatinine levels exceeding twice the upper limit of normal, or any other form of clinically significant renal impairment;
- Severe hepatic dysfunction, defined by ALT or AST levels greater than three times the upper limit of normal, or the presence of hepatic conditions such as acute or chronic hepatitis, cirrhosis, or other significant liver disorders;
- Comorbid conditions that may compromise study participation or pose substantial risk to the patient, including, but not limited to, alcohol or substance abuse, malignancies, and severe diseases affecting the liver, kidneys, lungs, endocrine system (e.g., uncontrolled diabetes or thyroid disorders), or hematopoietic system;
- Inability to cooperate with study procedures, whether due to cognitive, psychological, or physical factors that would impede compliance with protocol requirements;
- Other conditions deemed unsuitable by the investigator, including any medical or non-medical factors that, in the investigator's assessment, may preclude safe or effective participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Neurology, Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing
Yao Feng, Dr., +86 18810643595, fengyao_dr@sina.com
About this study
Perioperative neurological complications in cardiovascular surgical procedures are associated with a significant risk of mortality and disability. This study is aimed at identifying the specific risk factors associated with these neurological complications during the perioperation and developing a comprehensive predictive model designed to enhance clinical decision-making and improve patient safety. The research is divided into three key phases: preoperative, intraoperative, and postoperative, each involving targeted evaluations and continuous monitoring to provide a thorough assessment of patient risk and outcomes.
Read the detailed description
Before operation, a thorough assessment is conducted, encompassing a detailed analysis of participants' medical histories, demographic profiles, cerebrovascular structure, and cerebral function. These variables are systematically examined to identify risk factors for neurological complications.
Intraoperatively, real-time monitoring of cerebral blood flow and regional oxygen saturation is conducted using advanced techniques, including transcranial Doppler ultrasound and near-infrared spectroscopy, to evaluate the impact of surgical procedures on cerebral perfusion and oxygenation.
Postoperative monitoring emphasizes the identification of potential complications, such as cognitive dysfunction, seizures, delirium, and stroke. By integrating data from all stages during perioperation, the investigators want to develop a predictive model for perioperative brain function assessment. This model is intended to provide clinicians with a reliable tool for more precise risk assessment and timely intervention, thereby reducing the incidence of neurological complications and improving the prognosis for patients.
- Conditions
- Cardiac Surgery
- Being tested
- cardiac surgery
- Keywords
- cardiac surgery, stroke, cognitive function, delirium, risk factor, predictive model
- Medical subject headings
- Stroke, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac surgeryProcedure or surgery
All kinds of cardiac surgeries
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological complications within 7 (±3) days post-surgery including fatal or non-fatal stroke, coma, or movement disorders; cognitive dysfunction or delirium
Measured: From enrollment to the post-surgery within 7 (±3) days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start8 Feb 2025
- Primary completionJun 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,845 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shujuan Li, China National Center for Cardiovascular Diseases
- Investigators
- Li Shujuan, MD, Study director, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660602
- Sponsor's protocol ID
- 2024-2460
- Acronym
- PEACE
- Status last verified
- Mar 2025
- First submitted
- 21 Oct 2024
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gerstenecker 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 35804216Sultan 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 32199830Vermeer 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 12660385Gaudino M, Rahouma M, Di Mauro M, Yanagawa B, Abouarab A, Demetres M, Di Franco A, Arisha MJ, Ibrahim DA, Baudo M, Girardi LN, Fremes S. Early Versus Delayed Stroke After Cardiac Surgery: A Systematic Review and Meta-Analysis. J Am Heart Assoc. 2019 Jul 2;8(13):e012447. doi: 10.1161/JAHA.119.012447. Epub 2019 Jun 19.
PubMed 31215306Hillis LD, Smith PK, Anderson JL, Bittl JA, Bridges CR, Byrne JG, Cigarroa JE, Disesa VJ, Hiratzka LF, Hutter AM Jr, Jessen ME, Keeley EC, Lahey SJ, Lange RA, London MJ, Mack MJ, Patel MR, Puskas JD, Sabik JF, Selnes O, Shahian DM, Trost JC, Winniford MD. 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2011 Dec 6;124(23):e652-735. doi: 10.1161/CIR.0b013e31823c074e. Epub 2011 Nov 7. No abstract available.
PubMed 22064599
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Cerebral Function Assessment for Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06660602
- Acronym / sponsor ID
- PEACE / 2024-2460
- Conditions
- Cardiac Surgery
- Keywords
- cardiac surgery, stroke, cognitive function, delirium, risk factor, predictive model
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,845 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 8 Feb 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 28 Oct 2024 (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.
Perioperative neurological complications in cardiovascular surgical procedures are associated with a significant risk of mortality and disability. This study is aimed at identifying the specific risk factors associated with these neurological complications during the perioperation and developing a comprehensive predictive model designed to enhance clinical decision-making and improve patient safety. The research is divided into three key phases: preoperative, intraoperative, and postoperative, each involving targeted evaluations and continuous monitoring to provide a thorough assessment of patient risk and outcomes.
Detailed description
Before operation, a thorough assessment is conducted, encompassing a detailed analysis of participants' medical histories, demographic profiles, cerebrovascular structure, and cerebral function. These variables are systematically examined to identify risk factors for neurological complications.
Intraoperatively, real-time monitoring of cerebral blood flow and regional oxygen saturation is conducted using advanced techniques, including transcranial Doppler ultrasound and near-infrared spectroscopy, to evaluate the impact of surgical procedures on cerebral perfusion and oxygenation.
Postoperative monitoring emphasizes the identification of potential complications, such as cognitive dysfunction, seizures, delirium, and stroke. By integrating data from all stages during perioperation, the investigators want to develop a predictive model for perioperative brain function assessment. This model is intended to provide clinicians with a reliable tool for more precise risk assessment and timely intervention, thereby reducing the incidence of neurological complications and improving the prognosis for patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent cardiac surgeries
Key inclusion criteria (3 listed)
- Age 18-80 years;
- Patients undergoing cardiovascular surgical procedures;
- Able to understand and comply with the clinical trial protocol requirements, and willing to sign the informed consent form.
Key exclusion criteria (6 listed)
- Inability to tolerate required diagnostic procedures, including neck CT angiography (CTA), head CT perfusion (CTP), or electroencephalography (EEG), due to underlying physical limitations or medical contraindications;
- Severe renal insufficiency, characterized by a creatinine clearance of less than 30 mL/min (using the Cockcroft-Gault formula), serum creatinine levels exceeding twice the upper limit of normal, or any other form of clinically significant renal impairment;
- Severe hepatic dysfunction, defined by ALT or AST levels greater than three times the upper limit of normal, or the presence of hepatic conditions such as acute or chronic hepatitis, cirrhosis, or other significant liver disorders;
- Comorbid conditions that may compromise study participation or pose substantial risk to the patient, including, but not limited to, alcohol or substance abuse, malignancies, and severe diseases affecting the liver, kidneys, lungs, endocrine system (e.g., uncontrolled diabetes or thyroid disorders), or hematopoietic system;
- Inability to cooperate with study procedures, whether due to cognitive, psychological, or physical factors that would impede compliance with protocol requirements;
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 |
|---|---|---|
| cardiac surgeryAll kinds of cardiac surgeries | Procedure or surgery | – |
Primary outcome
Neurological complications within 7 (±3) days post-surgery including fatal or non-fatal stroke, coma, or movement disorders; cognitive dysfunction or delirium
Time frame: From enrollment to the post-surgery within 7 (±3) days
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 19 Mar 2025.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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.
- Results publication: PubMed 31215306Gaudino M, Rahouma M, Di Mauro M, Yanagawa B, Abouarab A, Demetres M, Di Franco A, Arisha MJ, Ibrahim DA, Baudo M, Girardi LN, Fremes S. Early Versus Delayed Stroke After Cardiac Surgery: A Systematic Review and Meta-Analysis. J Am Heart Assoc. 2019 Jul 2;8(13):e012447. doi: 10.1161/JAHA.119.012447. Epub 2019 Jun 19.
- Results publication: PubMed 22064599Hillis LD, Smith PK, Anderson JL, Bittl JA, Bridges CR, Byrne JG, Cigarroa JE, Disesa VJ, Hiratzka LF, Hutter AM Jr, Jessen ME, Keeley EC, Lahey SJ, Lange RA, London MJ, Mack MJ, Patel MR, Puskas JD, Sabik JF, Selnes O, Shahian DM, Trost JC, Winniford MD. 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2011 Dec 6;124(23):e652-735. doi: 10.1161/CIR.0b013e31823c074e. Epub 2011 Nov 7. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
Li Shujuan, MD study director
Chinese Academy of Medical Sciences, Fuwai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgery, run by China National Center for Cardiovascular Diseases at 1 site 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 6 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 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Yao Feng, Dr. (18810643595, fengyao_dr@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurological complications within 7 (±3) days post-surgery including fatal or non-fatal stroke, coma, or movement disorders; cognitive dysfunction or delirium (time frame: From enrollment to the post-surgery within 7 (±3) days). 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 NCT06660602, which also lists 5 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 19 Mar 2025.