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NCT Number: NCT05629000

Optimization 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.

Recruiting

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Key information

Conditions

Carotid Artery Stenosis Arterial Occlusive Diseases Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Carotid Stenosis Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Plaque, Amyloid Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

vascular surgery department of PUMCH

Beijing, Beijing Municipality, 100730, China

Location status: Recruiting

Location contact

Bao Liu, MD

PRINCIPAL_INVESTIGATOR

Changwei Liu, MD

PRINCIPAL_INVESTIGATOR

Feng Feng, MD

PRINCIPAL_INVESTIGATOR

Li Huo, MD

PRINCIPAL_INVESTIGATOR

Li Zhang, MD

SUB_INVESTIGATOR

Liangrui Zhou, MD

SUB_INVESTIGATOR

Meiqi Wu, MD

SUB_INVESTIGATOR

Xiaoyuan Fan, MD

SUB_INVESTIGATOR

Ying Wang, MD

SUB_INVESTIGATOR

Zhichao Lai, MD

CONTACT

[email protected]

01069152500

Zhichao Lai, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Carotid revascularization

Procedure

All patients received carotid revascularization surgery at Peking Union Medical College Hospital.

Other names: carotid endarterectomy and carotid artery stent

MRI-PWI

Diagnostic Test

Multi-modal MRI before and after surgery.

CTA

Diagnostic Test

CTA before and after surgery.

PET/MRI

Diagnostic Test

PET/MRI before surgery.

Ultrasound

Diagnostic Test

Ultrasound before and after surgery.

Primary outcomes

  1. stroke

    Time frame: During hospital stay, usually 7-30 days post operation

    perioperative stroke

  2. cardiac infarction

    Time frame: During hospital stay, usually 7-30 days post operation

    perioperative cardiac infarction

  3. transient ischemic attack

    Time frame: During hospital stay, usually 7-30 days post operation

    perioperative transient ischemic attack

  4. cerebral hyperperfusion syndrome

    Time frame: During hospital stay, usually 7-30 days post operation

    perioperative cerebral hyperperfusion syndrome

  5. death

    Time frame: During hospital stay, usually 7-30 days post operation

    perioperative death

Secondary outcomes

  1. Image characters of MRI

    Time frame: half year after operation

    Arterial transit times, cerebral blood flow, plaque characters, etc.

  2. Image characters of PET/MRI

    Time frame: half year after operation

    Diagnostic performance of 68Ga-FAPI PET/MR for intracranial or carotid atherosclerosis

  3. Image characters of ultrasound

    Time frame: half year after operation

    Diagnostic performance of carotid artery ultrasound for intracranial or carotid atherosclerosis

  4. Carotid plaque characters

    Time frame: half year after operation

    pathology characters of carotid plaque

Study contacts

Contact information is provided by the study sponsor or research team.

Zhichao Lai, MD

CONTACT

[email protected]

01069152500

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

Cohort of Optimized Assessment Strategy of Carotid Artery Stenosis

Acronym: COAS-CAS

Important dates

Study start
2015
Primary completion
2025
Study completion
2026
First posted
Nov 29, 2022
Registry last updated
Nov 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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