NCT05629000

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Jan 2015Dec 2026

Study Start

First participant enrolled

January 1, 2015

Completed
7.3 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2022

Completed
8 months until next milestone

First Posted

Study publicly available on registry

November 29, 2022

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

November 29, 2022

Status Verified

January 1, 2022

Enrollment Period

11 years

First QC Date

April 10, 2022

Last Update Submit

November 28, 2022

Conditions

Carotid Artery Stenosis

Keywords

carotid artery stenosisPerfusionplaqueMRICTPET/MRIUltrasound

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (4)

  • Image characters of MRI

    half year after operation

  • Image characters of PET/MRI

    half year after operation

  • Image characters of ultrasound

    half year after operation

  • Carotid plaque characters

    half year after operation

Study Arms (1)

Carotid artery stenosis

patient with carotid artery stenosis

Procedure: Carotid revascularizationDiagnostic Test: MRI-PWIDiagnostic Test: CTADiagnostic Test: PET/MRIDiagnostic Test: Ultrasound

Interventions

Carotid revascularizationPROCEDURE

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

Also known as: carotid endarterectomy and carotid artery stent
Carotid artery stenosis
MRI-PWIDIAGNOSTIC_TEST

Multi-modal MRI before and after surgery.

Carotid artery stenosis
CTADIAGNOSTIC_TEST

CTA before and after surgery.

Carotid artery stenosis
PET/MRIDIAGNOSTIC_TEST

PET/MRI before surgery.

Carotid artery stenosis
UltrasoundDIAGNOSTIC_TEST

Ultrasound before and after surgery.

Carotid artery stenosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

vascular surgery department of PUMCH

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (1)

  • 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: 38454421DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

plaques

MeSH Terms

Conditions

Carotid StenosisPlaque, Amyloid

Interventions

Endarterectomy, CarotidUltrasonography

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EndarterectomyVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Zhichao Lai, MD

CONTACT

01069152500zhichao_lai@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2022

First Posted

November 29, 2022

Study Start

January 1, 2015

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

November 29, 2022

Record last verified: 2022-01

Locations

CN(1)