Optimization Strategy of Carotid Artery Stenosis

Carotid Artery Stenosis Clinical Trial

— COAS-CAS  

Official title:

Cohort of Optimized Assessment Strategy of Carotid Artery Stenosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05629000
• Other study ID #: PUMCH-CAS-006
• Status: Recruiting
• Start date: January 1, 2015
• Est. completion date: December 31, 2026

Study information

• Verified date: January 2022
• Source: Peking Union Medical College Hospital
• Contact: Zhichao Lai, MD
• Phone: 01069152500
• Email: zhichao_lai[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carotid Artery Stenosis
• Carotid Stenosis
• Constriction, Pathologic

Intervention

Procedure:
• Carotid revascularization
All patients received carotid revascularization surgery at Peking Union Medical College Hospital.

Diagnostic Test:
• MRI-PWI
Multi-modal MRI before and after surgery.
• CTA
CTA before and after surgery.
• PET/MRI
PET/MRI before surgery.
• Ultrasound
Ultrasound before and after surgery.

Locations

Country	Name	City	State
China	vascular surgery department of PUMCH	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stroke	perioperative stroke	During hospital stay, usually 7-30 days post operation
Primary	cardiac infarction	perioperative cardiac infarction	During hospital stay, usually 7-30 days post operation
Primary	transient ischemic attack	perioperative transient ischemic attack	During hospital stay, usually 7-30 days post operation
Primary	cerebral hyperperfusion syndrome	perioperative cerebral hyperperfusion syndrome	During hospital stay, usually 7-30 days post operation
Primary	death	perioperative death	During hospital stay, usually 7-30 days post operation
Secondary	Image characters of MRI	Arterial transit times, cerebral blood flow, plaque characters, etc.	half year after operation
Secondary	Image characters of PET/MRI	Diagnostic performance of 68Ga-FAPI PET/MR for intracranial or carotid atherosclerosis	half year after operation
Secondary	Image characters of ultrasound	Diagnostic performance of carotid artery ultrasound for intracranial or carotid atherosclerosis	half year after operation
Secondary	Carotid plaque characters	pathology characters of carotid plaque	half year after operation