Integrated Assessment of Cervicocerebral Vessels to Improve the Brain Injury for CAGB Patients (IACV Study)

NCT06275139 | Recruiting DMC

• 1 other identifier: 2023-GSP-GG-9
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to establish a prospective study to focus on the high-risk stroke population who require coronary artery bypass graft surgery. It will divide the eligible patients into 1:1 group by simple randomization method. The control group adopt the traditional diagnosis and treatment mode, and only head CT plain scan and carotid artery ultrasound shall be performed. If necessary, relevant disciplines would be consulted but no integrated assessment of cervicocerebral vessels be arranged. The final treatment plan would be decided by the surgeon alone. The experimental group adopt the multidisciplinary collaboration and integrated evaluation mode. In addition to routine diagnosis and treatment as above-mentioned, integrated assessment of cervicocerebral vessels shall be performed, including transcranial color-coded doppler, cerebral perfusion with multislice CT, and cognitive function assessment. Based on the above results, surgical plans will be formulated jointly by multiple disciplines including neurologists, vascular surgeons, ICU physicians and cardiac surgeons. Researchers will compare the two groups to investigate whether integrated assessment of cervicocerebral vessels can reduce the incidence of brain injury compared with conventional diagnosis and treatment mode.

Conditions

Coronary Disease; Coronary Artery Bypass; Strokes Thrombotic

Keywords

Coronary Disease; Coronary artery bypass; Stroke

Outcome Measures

Primary Outcomes (1)

• The incidence of neurological complications

  Diagnosed by clinical manifestation, brain CT or MRI

  Within three months after surgery

Secondary Outcomes (2)

• The incidence of major adverse cardiac events

  Within three months after surgery

• Neurological scale scores

  Within 3 months after surgery

Study Arms (2)

Control group (No-integrated group)

NO INTERVENTION

The control group adopt the traditional diagnosis and treatment mode, and only head CT plain scan and carotid artery ultrasound shall be performed. If necessary, relevant disciplines would be consulted but no integrated assessment of cervicocerebral vessels be arranged. The final treatment plan would be decided by the surgeon alone.

Experimental group (Integrated group)

EXPERIMENTAL

The experimental group adopt the multidisciplinary collaboration and integrated evaluation mode. In addition to routine diagnosis and treatment as above-mentioned, integrated assessment of cervicocerebral vessels shall be performed, including transcranial color-coded doppler, cerebral perfusion with multislice CT, and cognitive function assessment. Based on the above results, surgical plans will be formulated jointly by multiple disciplines including neurologists, vascular surgeons, ICU physicians and cardiac surgeons.

Other: Integrated Assessment of Cervicocerebral Vessels

Interventions

Integrated Assessment of Cervicocerebral Vessels OTHER

Integrated assessment of cervicocerebral vessels shall be performed, including transcranial color-coded doppler, cerebral perfusion with multislice CT, and cognitive function assessment.

Experimental group (Integrated group)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who require CABG surgery; Age ≥18 years with a history of stroke or transient ischemic attack; Combined with typical symptoms of stroke; Previous imaging findings suggest a high risk of stroke

You may not qualify if:

• \< 18 years old; \> 80 years old; Combined with congenital cerebrovascular malformation; Emergency operation; Reluctant to sign an informed consent form; Reluctant to follow up

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai Hospital; National Cardiovascular Center; Peking Union Medical College & Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100037, China

RECRUITING

Related Publications (17)

• Ottens TH, Dieleman JM, Sauer AM, Peelen LM, Nierich AP, de Groot WJ, Nathoe HM, Buijsrogge MP, Kalkman CJ, van Dijk D; DExamethasone for Cardiac Surgery (DECS) Study Group. Effects of dexamethasone on cognitive decline after cardiac surgery: a randomized clinical trial. Anesthesiology. 2014 Sep;121(3):492-500. doi: 10.1097/ALN.0000000000000336.

  PMID: 25225745 RESULT

• Greaves D, Psaltis PJ, Davis DHJ, Ross TJ, Ghezzi ES, Lampit A, Smith AE, Keage HAD. Risk Factors for Delirium and Cognitive Decline Following Coronary Artery Bypass Grafting Surgery: A Systematic Review and Meta-Analysis. J Am Heart Assoc. 2020 Nov 17;9(22):e017275. doi: 10.1161/JAHA.120.017275. Epub 2020 Nov 7.

  PMID: 33164631 RESULT

• Kumpaitiene B, Svagzdiene M, Sirvinskas E, Adomaitiene V, Petkus V, Zakelis R, Krakauskaite S, Chomskis R, Ragauskas A, Benetis R. Cerebrovascular autoregulation impairments during cardiac surgery with cardiopulmonary bypass are related to postoperative cognitive deterioration: prospective observational study. Minerva Anestesiol. 2019 Jun;85(6):594-603. doi: 10.23736/S0375-9393.18.12358-3. Epub 2018 May 11.

  PMID: 29756691 RESULT

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  PMID: 29956559 RESULT

• Hill NT, Mowszowski L, Naismith SL, Chadwick VL, Valenzuela M, Lampit A. Computerized Cognitive Training in Older Adults With Mild Cognitive Impairment or Dementia: A Systematic Review and Meta-Analysis. Am J Psychiatry. 2017 Apr 1;174(4):329-340. doi: 10.1176/appi.ajp.2016.16030360. Epub 2016 Nov 14.

  PMID: 27838936 RESULT

• Yilmaz S, Aksoy E, Diken AI, Yalcinkaya A, Erol ME, Cagli K. Dopamine Administration is a Risk Factor for Delirium in Patients Undergoing Coronary Artery Bypass Surgery. Heart Lung Circ. 2016 May;25(5):493-8. doi: 10.1016/j.hlc.2015.09.012. Epub 2015 Oct 22.

  PMID: 26546094 RESULT

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  PMID: 27344279 RESULT

• Eide LS, Ranhoff AH, Fridlund B, Haaverstad R, Hufthammer KO, Kuiper KK, Nordrehaug JE, Norekval TM; CARDELIR Investigators. Comparison of frequency, risk factors, and time course of postoperative delirium in octogenarians after transcatheter aortic valve implantation versus surgical aortic valve replacement. Am J Cardiol. 2015 Mar 15;115(6):802-9. doi: 10.1016/j.amjcard.2014.12.043. Epub 2015 Jan 6.

  PMID: 25644851 RESULT

• Colak Z, Borojevic M, Bogovic A, Ivancan V, Biocina B, Majeric-Kogler V. Influence of intraoperative cerebral oximetry monitoring on neurocognitive function after coronary artery bypass surgery: a randomized, prospective study. Eur J Cardiothorac Surg. 2015 Mar;47(3):447-54. doi: 10.1093/ejcts/ezu193. Epub 2014 May 7.

  PMID: 24810757 RESULT

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  PMID: 25516034 RESULT

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  PMID: 22778141 RESULT

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  PMID: 21168339 RESULT

• Liu YH, Wang DX, Li LH, Wu XM, Shan GJ, Su Y, Li J, Yu QJ, Shi CX, Huang YN, Sun W. The effects of cardiopulmonary bypass on the number of cerebral microemboli and the incidence of cognitive dysfunction after coronary artery bypass graft surgery. Anesth Analg. 2009 Oct;109(4):1013-22. doi: 10.1213/ane.0b013e3181aed2bb.

  PMID: 19762724 RESULT

• Scott DA, Silbert BS, Doyle TJ, Blyth C, Borton MC, O'brien JL, de L Horne DJ. Centrifugal versus roller head pumps for cardiopulmonary bypass: effect on early neuropsychologic outcomes after coronary artery surgery. J Cardiothorac Vasc Anesth. 2002 Dec;16(6):715-22. doi: 10.1053/jcan.2002.128413.

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  PMID: 37647926 RESULT

• Izzy M, Fortune BE, Serper M, Bhave N, deLemos A, Gallegos-Orozco JF, Guerrero-Miranda C, Hall S, Harinstein ME, Karas MG, Kriss M, Lim N, Palardy M, Sawinski D, Schonfeld E, Seetharam A, Sharma P, Tallaj J, Dadhania DM, VanWagner LB. Management of cardiac diseases in liver transplant recipients: Comprehensive review and multidisciplinary practice-based recommendations. Am J Transplant. 2022 Dec;22(12):2740-2758. doi: 10.1111/ajt.17049. Epub 2022 Apr 22.

  PMID: 35359027 RESULT

MeSH Terms

Conditions

Coronary Disease; Thrombotic Stroke; Stroke

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Ischemic Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Fei Xu, MD

  Fuwai Hospital; National Cardiovascular Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guanxi Wang, MD

CONTACT

01088322355; FYguanxiwang@163.com

Sen Zhang, MD

CONTACT

01088322356; zs00076@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Integrated assessment of cervicocerebral vessels shall be performed, including transcranial color-coded doppler, cerebral perfusion with multislice CT, and cognitive function assessment.

Study Record Dates

• First Submitted: February 17, 2024
• First Posted: February 23, 2024
• Study Start: January 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)