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Recruiting NCT05629000

Optimization Strategy of Carotid Artery Stenosis

Observational Carotid Artery Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Carotid revascularization, MRI-PWI, CTA, PET/MRI.
Who it may be relevant to
Registry conditions: Carotid Artery Stenosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Cohort of Optimized Assessment Strategy of Carotid Artery Stenosis

Overview

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.

Interventions

  • 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.
  • Diagnostic test CTA
    CTA before and after surgery.
  • Diagnostic test PET/MRI
    PET/MRI before surgery.
  • Diagnostic test Ultrasound
    Ultrasound before and after surgery.

Primary outcome measures

  • stroke [Time frame: During hospital stay, usually 7-30 days post operation]
  • cardiac infarction [Time frame: During hospital stay, usually 7-30 days post operation]
  • transient ischemic attack [Time frame: During hospital stay, usually 7-30 days post operation]
  • cerebral hyperperfusion syndrome [Time frame: During hospital stay, usually 7-30 days post operation]
  • death [Time frame: During hospital stay, usually 7-30 days post operation]
Secondary outcome measures (4)
  • Image characters of MRI [Time frame: half year after operation]
  • Image characters of PET/MRI [Time frame: half year after operation]
  • Image characters of ultrasound [Time frame: half year after operation]
  • Carotid plaque characters [Time frame: half year after operation]

Eligibility criteria

Inclusion criteria

  • patients with severe stenosis (≥50%) or near-occlusion diagnosed by computed tomographic angiogram;
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • vascular surgery department of PUMCH — Beijing

Publications

  • Lai Z, Wang C, Liu X, Sun H, Guo Z, Shao J, Li K, Chen J, Wang J, Lei X, Shu K, Feng Y, Kong D, Sun W, Liu B. Characterization of the proteome of stable and unstable carotid atherosclerotic plaques using data-independent acquisition mass spectrometry. J Transl Med. 2024 Mar 7;22(1):247. doi: 10.1186/s12967-023-04723-1. PMID 38454421

Identifiers

NCT: NCT05629000 · PUMCH-CAS-006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗