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

NCT ID: NCT06275139

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 348 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-12-31

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.

Detailed 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.

Conditions

Coronary Disease; Coronary Artery Bypass; Strokes Thrombotic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control group (No-integrated group)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Experimental group (Integrated group)

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.

Group Type: EXPERIMENTAL

Integrated Assessment of Cervicocerebral Vessels

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fei Xu, MD

Role: PRINCIPAL_INVESTIGATOR

Fuwai Hospital; National Cardiovascular Center

Locations

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

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Guanxi Wang, MD

Role: CONTACT

FYguanxiwang@163.com

01088322355

Sen Zhang, MD

Role: CONTACT

zs00076@163.com

01088322356

Facility Contacts

Huanmei Liu, MD

Role: primary

ncrc@fuwai.com

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Other Identifiers

2023-GSP-GG-9

Identifier Type: -

Identifier Source: org_study_id