Optimization Strategy of Carotid Artery Stenosis (COAS-CAS)

Cohort of Optimized Assessment Strategy of Carotid Artery Stenosis

The goal of this observational study is to learn about how to utilize multiple evaluation techniques in carotid artery stenosis patients for optimizing assessment of diagnosis and treatment strategy.

The main questions it aims to answer are:

• Identify best strategy that use multi-modal MRI and CT to assess patients' cerebral lesions and perfusion.
• Identify best strategy that use multi-modal MRI, PET-MRI ultrasound and CT to assess components and characters of patients' carotid plaques.

Participants will accept imaging examination before and after surgery. And doctors will collect basic characteristics, imaging results and biological samples of patients for analysis.

Study Overview

• Status: Recruiting
• Conditions: Carotid Artery Stenosis
• Intervention / Treatment: Procedure: Carotid revascularization; Diagnostic test: MRI-PWI; Diagnostic test: CTA; Diagnostic test: PET/MRI; Diagnostic test: Ultrasound

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Zhichao Lai, MD; Phone Number: 01069152500; Email: zhichao_lai@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • vascular surgery department of PUMCH
      • Principal Investigator: Bao Liu, MD
      • Principal Investigator: Li Huo, MD
      • Contact: Zhichao Lai, MD; Phone Number: 01069152500; Email: zhichao_lai@126.com
      • Principal Investigator: Zhichao Lai, MD
      • Principal Investigator: Feng Feng, MD
      • Sub-Investigator: Meiqi Wu, MD
      • Sub-Investigator: Xiaoyuan Fan, MD
      • Sub-Investigator: Ying Wang, MD
      • Sub-Investigator: Li Zhang, MD
      • Sub-Investigator: Liangrui Zhou, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Mild to severe carotid stenosis or near-occlusion patients receiving carotid revascularization treatment.

Description

Inclusion Criteria:

1. patients with severe stenosis (≥50%) or near-occlusion diagnosed by computed tomographic angiogram;
2. patients received carotid endarterectomy at Peking Union Medical College Hospital

Exclusion Criteria:

(1) Any contraindication to image examination; (3) refuse to sign the Informed consent.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Carotid artery stenosis; patient with carotid artery stenosis

Procedure: Carotid revascularization; All patients received carotid revascularization surgery at Peking Union Medical College Hospital.; Other Names: carotid endarterectomy and carotid artery stent; Diagnostic test: MRI-PWI; Multi-modal MRI before and after surgery.; Diagnostic test: CTA; CTA before and after surgery.; Diagnostic test: PET/MRI; PET/MRI before surgery.; Diagnostic test: Ultrasound; Ultrasound before and after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
stroke	perioperative stroke	During hospital stay, usually 7-30 days post operation
cardiac infarction	perioperative cardiac infarction	During hospital stay, usually 7-30 days post operation
transient ischemic attack	perioperative transient ischemic attack	During hospital stay, usually 7-30 days post operation
cerebral hyperperfusion syndrome	perioperative cerebral hyperperfusion syndrome	During hospital stay, usually 7-30 days post operation
death	perioperative death	During hospital stay, usually 7-30 days post operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Image characters of MRI	Arterial transit times, cerebral blood flow, plaque characters, etc.	half year after operation
Image characters of PET/MRI	Diagnostic performance of 68Ga-FAPI PET/MR for intracranial or carotid atherosclerosis	half year after operation
Image characters of ultrasound	Diagnostic performance of carotid artery ultrasound for intracranial or carotid atherosclerosis	half year after operation
Carotid plaque characters	pathology characters of carotid plaque	half year after operation

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: April 10, 2022
• First Submitted That Met QC Criteria: November 28, 2022
• First Posted (Actual): November 29, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: MRI; Ultrasound; CT; PET/MRI; plaque; Perfusion; carotid artery stenosis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Carotid Artery Diseases; Carotid Stenosis; Constriction, Pathologic
• Other Study ID Numbers: PUMCH-CAS-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No