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

Официальное название

A Multi-center Prospective Cohort Study on the Evaluation of Vulnerability of Carotid Artery Plaques and Prediction of Cardio-Cerebrovascular Event Risk Using Ultrasonic Imaging

Обзор

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.

Подробное описание

This study is a prospective multi-center cohort study that aims to collect 600 patients with carotid artery plaques (including over 66,000 multimodal ultrasound image data), with patients coming from five participating centers. Starting from the collection of cases, the follow-up period is 36 months, during which the occurrence of cardiovascular and cerebrovascular events in patients will be observed. The relationship between multimodal ultrasonic imaging indicators, the vulnerability of carotid plaques, and cardiovascular and cerebrovascular events will be explored. Based on this, a cardiovascular and cerebrovascular risk prediction model for patients with carotid artery plaques will be established, forming a risk warning tool suitable for clinical use.

Inclusion criteria:

1. Patients who fully understand the purpose and significance of this experiment, voluntarily participate, and voluntarily sign the informed consent form; 2. Patients over 40 years old; 3. 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.

Exclusion criteria:

1. Patients with severe cardiopulmonary insufficiency; allergy to sulfur hexafluoride; pregnant or lactating women; those with advanced tumors; 2. Poor quality of ultrasound images; 3. Patients who have previously undergone carotid artery stenting or endarterectomy on the same side as the carotid plaque.

The study aims to complete the establishment of an imaging database for 600 patients undergoing ultrasound examinations for carotid artery plaques, follow them up for 36 months, and record whether cardiovascular and cerebrovascular diseases occur.

Вмешательства

• Другое Cardiovascular and cerebrovascular diseases
  Cardiovascular and cerebrovascular diseases

Первичные конечные точки

• IPN semi-quantitative grading [Срок оценки: 36 months]

Вторичные конечные точки (3)

• Plaque volume (mm^3) [Срок оценки: 36 months]
• Average shear wave velocity [Срок оценки: 36 months]
• Ulceration and low-echo regions (if present) [Срок оценки: 36 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Shanghai General Hospital — Шанхай

Идентификаторы

NCT: NCT06473272 · Shanghai1st-WR

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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