Study of Carotid Artery Stenosis Through the Integration of Multimodal Imaging and Computational Fluid Dynamics

March 4, 2024 updated by: Lei Guo, Sichuan Provincial People's Hospital

Perioperative Risk and Clinical Efficacy Study of Cervical Artery Stenosis Patients Through the Integration of Multimodal Imaging and Computational Fluid Dynamics

Ischemic stroke affects 2.5 to 3 million people annually in China, ranking as the leading cause of death and disability. Cervical artery stenosis is a significant contributor to this problem, with about 50% of patients experiencing cognitive impairment due to reduced cerebral blood flow. Two main surgical approaches, carotid endarterectomy (CEA) and carotid artery stenting (CAS), are used to treat severe cervical artery stenosis, but their effects on various factors remain unclear.

This project collects multimodal imaging data, including CT perfusion and angiography, to create 3D models of cervical artery stenosis. Computational fluid dynamics and AI analysis are used to assess hemodynamics. By monitoring blood flow, oxygen levels, and evaluating postoperative outcomes, the goal is to tailor surgical approaches for better patient outcomes and improved quality of life.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In China, the annual incidence of ischemic stroke is estimated to be between 2.5 to 3 million cases, making it the leading cause of death and disability among the population. Among these cases, cervical artery stenosis is a significant independent risk factor for ischemic stroke. Approximately 50% of patients with cervical artery stenosis are prone to develop vascular-related cognitive impairment due to cerebral hypoperfusion, severely affecting human health and quality of life.

There are currently two main surgical approaches for treating severe cervical artery stenosis: carotid endarterectomy (CEA) and carotid artery stenting (CAS). The effects of these two surgical methods on preoperative and postoperative intracranial and extracranial hemodynamic changes, the mechanisms underlying perioperative complications, the establishment of collateral circulation, and long-term prognosis remain unclear. Therefore, researching perioperative risk assessment and clinical efficacy of different surgical approaches is of great significance for patient outcomes.

This project aims to collect multimodal imaging data from patients with cervical artery stenosis, including brain CT perfusion imaging and CT angiography. Using artificial intelligence algorithms, three-dimensional models of cervical artery stenosis will be reconstructed, and computational fluid dynamics will be employed to automatically or semi-automatically analyze the hemodynamic characteristics of patients' carotid arteries. By monitoring cerebral blood flow velocity, local cerebral oxygen metabolism, and assessing postoperative stroke, ischemia-reperfusion injury, and collateral circulation both intracranially and extracranially, precise evaluations will be conducted.

Based on individual patient characteristics, the surgical approach can be optimized to prevent cerebral ischemia-reperfusion injury, improve clinical prognosis, and enhance the quality of life for patients.

Study Type

Observational

Enrollment (Estimated)

40

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
    • Sichuan
      • Chengdu, Sichuan, China, 610072
        • Recruiting
        • Sichuan Provincial People's Hospital
        • Contact:
        • Sub-Investigator:
          • Chaoqun Zeng, Ph.D.

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

Sampling Method

Non-Probability Sample

Study Population

Adults aged between 18 and 80 years old

Description

Inclusion Criteria:

1) Clinical diagnosis of carotid stenosis.

Exclusion Criteria:

  1. Vascular stenosis with vascular malformations.
  2. Aneurysm.
  3. Severe heart, liver, or kidney disease.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CEA group
The patient with carotid stenosis underwent CEA surgery.
Procedure: CEA/CAS
carotid endarterectomy (CEA) and carotid artery stenting (CAS)
CAS group
The patient with carotid stenosis underwent CAS treatment.
Procedure: CEA/CAS
carotid endarterectomy (CEA) and carotid artery stenting (CAS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative cardio-cerebrovascular adverse events
Time Frame: 2 weeks after surgery
Specific adverse events related to the cardiovascular and cerebrovascular systems that may occur during the perioperative period , encompassing the time before, during, and after a CEA. These events include myocardial infarction (heart attack), cerebral hyperperfusion injury, stroke, arrhythmias (abnormal heart rhythms), and death.
2 weeks after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compute fluid dynamics parameters
Time Frame: 1 day before the surgery, 3 days after the surgery
Based on computational fluid dynamics, calculate the changes in hemodynamic parameters after CEA patients, including Shear Stress (Pa), Flow Velocity (cm/s), Wall Pressure (Pa)
1 day before the surgery, 3 days after the surgery
Clinical outcome
Time Frame: 6 months after surgery
The clinical outcome was assessed at 6 months after treatment using the mRS score, and a good outcome was defined as a modified Rankin Scale (mRS) score of 0-2 at 6 months after surgery.
6 months after surgery

Collaborators and Investigators

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

Sponsor

Sichuan Provincial People's Hospital

Investigators

  • Principal Investigator: Chunling Li, MD, Sichuan Provincial People's Hospital

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)

June 1, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

September 16, 2023

First Submitted That Met QC Criteria

March 4, 2024

First Posted (Actual)

March 5, 2024

Study Record Updates

Last Update Posted (Actual)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023YFS0274

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After the research is completed, it is possible to share the research plan and research report with other researchers.

IPD Sharing Time Frame

After the completion of the research

IPD Sharing Access Criteria

Data are available upon reasonable request (guolleii2021@hotmail.com).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

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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