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

February 17, 2024 updated by: China National Center for Cardiovascular Diseases

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

348

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100037
        • Recruiting
        • Fuwai Hospital; National Cardiovascular Center; Peking Union Medical College & Chinese Academy of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of neurological complications
Time Frame: Within three months after surgery
Diagnosed by clinical manifestation, brain CT or MRI
Within three months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of major adverse cardiac events
Time Frame: Within three months after surgery
Diagnosed by follow up
Within three months after surgery
Neurological scale scores
Time Frame: Within 3 months after surgery
Measured by using neurological system scale
Within 3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China National Center for Cardiovascular Diseases

Investigators

  • Principal Investigator: Fei Xu, MD, Fuwai Hospital; National Cardiovascular Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

February 17, 2024

First Submitted That Met QC Criteria

February 17, 2024

First Posted (Estimated)

February 23, 2024

Study Record Updates

Last Update Posted (Estimated)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 17, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-GSP-GG-9

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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