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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:
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:
Exclusion criteria:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Symptomatic group | The symptomatic group consisted of patients who were diagnosed with their first ipsilateral ischemic lesions in the carotid territory (anterior circulation) based on head computed tomography (CT) or magnetic resonance imaging (MRI) conducted within the previous 8 weeks. |
| |
| Asymptomatic group | The asymptomatic group included patients who showed no intracranial ischemic lesions on head CT/MRI images and exhibited no neurological symptoms. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiovascular and cerebrovascular diseases | Other | Cardiovascular and cerebrovascular diseases |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Plaque volume (mm^3) | using the software package provided with the ultrasound machine or post-processing software | 36 months |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with carotid plaque
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rong Wu, Dr | Contact | +021-18917683516 | wurong7111@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Rong Wu, Dr | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai General Hospital | Recruiting | Shanghai | Shanghai Municipality | 200080 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 30, 2024 |
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| 36 months |
| Ulceration and low-echo regions (if present) | The largest area of surface ulceration and low-echo regions within the plaque | 36 months |
| Jun 4, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 30, 2024 | Jun 18, 2024 | ICF_001.pdf |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001775 | Blood Circulation |
| ID | Term |
|---|---|
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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