Evaluation of Vulnerability of Carotid Plaques and Prediction of Cardio-Cerebrovascular Event Using Ultrasonic Imaging
NCT ID: NCT06473272
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
600 participants
OBSERVATIONAL
2024-07-01
2027-12-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Cardiovascular and cerebrovascular diseases
Cardiovascular and cerebrovascular diseases
Asymptomatic group
The asymptomatic group included patients who showed no intracranial ischemic lesions on head CT/MRI images and exhibited no neurological symptoms.
No interventions assigned to this group
Interventions
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Cardiovascular and cerebrovascular diseases
Cardiovascular and cerebrovascular diseases
Eligibility Criteria
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Inclusion Criteria
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
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.
40 Years
100 Years
ALL
No
Sponsors
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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Rong Wu
Principal Investigator
Principal Investigators
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Rong Wu, Dr
Role: PRINCIPAL_INVESTIGATOR
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Locations
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Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Rong Wu, Dr
Role: primary
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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Shanghai1st-WR
Identifier Type: -
Identifier Source: org_study_id