Optimization Strategy of Carotid Artery Stenosis

Recruiting

• Conditions: Carotid Artery Stenosis
• Interventions: Procedure: Carotid revascularization; Diagnostic Test: MRI-PWI; Diagnostic Test: CTA; Diagnostic Test: PET/MRI; Diagnostic Test: Ultrasound

• Registration Number: NCT05629000
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-01
• Status Verified: 2022-01
• Study First Submitted: 2022-04-10
• Study First Submitted QC: 2022-11-28
• Last Update Submitted: 2022-11-28
• Study First Posted: 2022-11-29
• Last Update Posted: 2022-11-29
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Carotid artery stenosis	Carotid revascularization	patient with carotid artery stenosis
Carotid artery stenosis	MRI-PWI	patient with carotid artery stenosis
Carotid artery stenosis	PET/MRI	patient with carotid artery stenosis
Carotid artery stenosis	Ultrasound	patient with carotid artery stenosis
Carotid artery stenosis	CTA	patient with carotid artery stenosis

Primary Outcome Measures

Name	Time	Method
cardiac infarction	During hospital stay, usually 7-30 days post operation	perioperative cardiac infarction
transient ischemic attack	During hospital stay, usually 7-30 days post operation	perioperative transient ischemic attack
death	During hospital stay, usually 7-30 days post operation	perioperative death
stroke	During hospital stay, usually 7-30 days post operation	perioperative stroke
cerebral hyperperfusion syndrome	During hospital stay, usually 7-30 days post operation	perioperative cerebral hyperperfusion syndrome

Secondary Outcome Measures

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

Trial Locations

Locations (1)

vascular surgery department of PUMCH; 🇨🇳 Beijing, Beijing, China