Assessing Carotid Plaque Vulnerability to Predict Stroke and Heart Events
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
This study is trying to see if special ultrasound tests can help predict the risk of strokes and heart problems in people with plaque in their carotid arteries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 40 Years to 100 Years |
| Sex | All |
| Sponsor | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06473272 on ClinicalTrials.gov |
What this trial studies
This observational study involves patients with carotid artery atherosclerotic plaques who will undergo various multimodal ultrasound examinations. The goal is to establish a model for assessing plaque vulnerability using ultrasonic imaging indicators, clinical history, and laboratory data. Over a follow-up period of three years, the study will observe the occurrence of cardiovascular and cerebrovascular events to explore the correlation between plaque vulnerability and these events. Ultimately, a risk prediction model will be developed to aid in clinical risk management for patients with carotid artery plaques.
Who should consider this trial
Good fit: Ideal candidates are individuals over 40 years old with carotid plaque thickness of 1.5 mm or more.
Not a fit: Patients with severe cardiopulmonary insufficiency, advanced tumors, or those who have undergone prior carotid artery procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable tool for predicting cardiovascular and cerebrovascular events in patients with carotid plaques.
How similar studies have performed: Other studies have shown promise in using imaging techniques to assess plaque vulnerability, indicating that this approach has potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai General Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Rong Wu, Dr — Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Study coordinator: Rong Wu, Dr
- Email: wurong7111@163.com
- Phone: +021-18917683516
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.