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

Coronary Disease Clinical Trial

Official title:

Integrated Assessment of Cervicocerebral Vessels by Multidisciplinary Team to Improve the Brain Injury for CAGB Patients With High Risk of Stroke (IACV Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06275139
• Other study ID #: 2023-GSP-GG-9
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: China National Center for Cardiovascular Diseases
• Contact: Guanxi Wang, MD
• Phone: 01088322355
• Email: FYguanxiwang[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Brain injury is one of the most important factors leading to poor prognosis of CABG surgery, especially for high-risk patients. In order to reduce brain injury after cardiac surgery, preoperative assessment and management are particularly important. Multidisciplinary diagnosis and treatment mode (multidisciplinary team, MDT) refers to a multidisciplinary clinical work team, usually a fixed working group composed of several related disciplines. MDT carries out routine clinical discussions for difficult and complex disease and develop accurate and effective individualized treatment plans for patients, which has become the mainstream trend. The traditional treatment mode mainly relies on head CT and carotid ultrasound to evaluate the nervous system, and then the surgeon decides the operation mode according to experience, ignoring the role of related disciplines, including neurologists, vascular surgeons, ICU physicians and cardiac surgeons. We believe that integrated assessment of cervicocerebral vessels will help reduce the incidence of brain injury in high-risk patients. This study is an exploratory attempt for high-risk patients, which can provide more evidence for the prevention of perioperative neurological complications of CABG, and is of great significance for reducing disease burden, ensuring surgical safety, and improving the long-term prognosis of patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 348
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Brain Injuries
• Coronary Artery Bypass
• Coronary Artery Disease
• Coronary Disease
• Stroke
• Strokes Thrombotic
• Thrombotic Stroke

Intervention

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

Locations

Country	Name	City	State
China	Fuwai Hospital; National Cardiovascular Center; Peking Union Medical College & Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

References & Publications (17)

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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( — View Citation

Harmon DC, Ghori KG, Eustace NP, O'Callaghan SJ, O'Donnell AP, Shorten GD. Aprotinin decreases the incidence of cognitive deficit following CABG and cardiopulmonary bypass: a pilot randomized controlled study. Can J Anaesth. 2004 Dec;51(10):1002-9. doi: 1 — View Citation

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 — View Citation

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Leenders J, Overdevest E, van Straten B, Golab H. The influence of oxygen delivery during cardiopulmonary bypass on the incidence of delirium in CABG patients; a retrospective study. Perfusion. 2018 Nov;33(8):656-662. doi: 10.1177/0267659118783104. Epub 2 — View Citation

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 A — View Citation

Marijon E, Narayanan K, Smith K, Barra S, Basso C, Blom MT, Crotti L, D'Avila A, Deo R, Dumas F, Dzudie A, Farrugia A, Greeley K, Hindricks G, Hua W, Ingles J, Iwami T, Junttila J, Koster RW, Le Polain De Waroux JB, Olasveengen TM, Ong MEH, Papadakis M, S — View Citation

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 — View Citation

Palmbergen WA, van Sonderen A, Keyhan-Falsafi AM, Keunen RW, Wolterbeek R. Improved perioperative neurological monitoring of coronary artery bypass graft patients reduces the incidence of postoperative delirium: the Haga Brain Care Strategy. Interact Card — View Citation

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;1 — View Citation

Siepe M, Pfeiffer T, Gieringer A, Zemann S, Benk C, Schlensak C, Beyersdorf F. Increased systemic perfusion pressure during cardiopulmonary bypass is associated with less early postoperative cognitive dysfunction and delirium. Eur J Cardiothorac Surg. 201 — View Citation

van Meenen LC, van Meenen DM, de Rooij SE, ter Riet G. Risk prediction models for postoperative delirium: a systematic review and meta-analysis. J Am Geriatr Soc. 2014 Dec;62(12):2383-90. doi: 10.1111/jgs.13138. — View Citation

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 — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of neurological complications	Diagnosed by clinical manifestation, brain CT or MRI	Within three months after surgery
Secondary	The incidence of major adverse cardiac events	Diagnosed by follow up	Within three months after surgery
Secondary	Neurological scale scores	Measured by using neurological system scale	Within 3 months after surgery