Evaluation of Vulnerability of Carotid Plaques and Prediction of Cardio-Cerebrovascular Event Using Ultrasonic Imaging

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-100
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine

About this trial

This study included patients with carotid artery atherosclerotic plaques to conduct multimodal ultrasound examinations, aiming to establish a plaque vulnerability assessment model based on ultrasonic imaging indicators, clinical history, and laboratory indicators. Based on the occurrence of cardiovascular and cerebrovascular events during the 3-year follow-up period, the correlation between the vulnerability of carotid plaques and the occurrence of cardiovascular and cerebrovascular events was explored. Furthermore, a cardiovascular and cerebrovascular risk prediction model for patients with plaques was established by combining multi-dimensional data indicators such as patients\' clinical data and ultrasonic multimodal imaging data, forming a risk warning tool suitable for clinical use and providing a reference for risk management in patients with carotid artery plaques.

Research Objectives:

1. To establish a plaque vulnerability assessment model based on ultrasonic imaging indicators of plaques, clinical indicators of patients, and laboratory indicators. 2. To establish a cardiovascular and cerebrovascular risk prediction model for patients with carotid plaques by combining clinical indicators of patients and ultrasonic multimodal imaging data. 3. To screen ultrasonic imaging indicators for predicting cardiovascular and cerebrovascular events.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients who fully understand the purpose and significance of this experiment, voluntarily participate, and voluntarily sign the informed consent form;

Patients over 40 years old;

Patients with carotid plaque thickness ≥ 1.5 mm on conventional ultrasound, undergoing routine duplex ultrasound, contrast-enhanced ultrasound, ultrasound elastography, and three-dimensional ultrasound imaging.

Disqualifiers

Patients with severe cardiopulmonary insufficiency; allergy to sulfur hexafluoride; pregnant or lactating women; those with advanced tumors;

Poor quality of ultrasound images;

Patients who have previously undergone carotid artery stenting or endarterectomy on the same side as the carotid plaque.

Trial population

Patients with carotid plaque

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Cardiovascular and cerebrovascular diseases

    Other intervention

    Cardiovascular and cerebrovascular diseases

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: Symptomatic group1 intervention
Group B: Asymptomatic group0 interventions

Trial outcomes

Primary outcomes

1

IPN semi-quantitative grading

Grade 0: no microbubbles seen within the plaque; Grade 1: microbubbles limited to the plaque shoulder or adventitial surface; Grade 2: microbubbles visible at the thickest part of the plaque, the intimal surface, or extensive enhancement within the plaque

Time frame
36 months

Secondary outcomes

1

Plaque volume (mm^3)

using the software package provided with the ultrasound machine or post-processing software

Time frame
36 months
2

Average shear wave velocity

After obtaining a stable grayscale image, select the shear wave elastography (SWE) mode and adjust the region of interest (ROI) to include the entire plaque. During the examination, ensure that the probe only has minimal contact with the skin to minimize compression artifacts. Freeze the image after stabilization, acquire the elastography image, and use the tracking tool to accurately outline the plaque boundary to obtain the average shear wave velocity (SWV).

Time frame
36 months
3

Ulceration and low-echo regions (if present)

The largest area of surface ulceration and low-echo regions within the plaque

Time frame
36 months

Other outcomes

Sponsors and contacts

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