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

NCT06473272 | Recruiting

• 1 other identifier: Shanghai1st-WR
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.To establish a plaque vulnerability assessment model based on ultrasonic imaging indicators of plaques, clinical indicators of patients, and laboratory indicators.
2. 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. 3.To screen ultrasonic imaging indicators for predicting cardiovascular and cerebrovascular events.

Conditions

Carotid Plaque; Ischemic Stroke; Cardiovascular Events

Outcome Measures

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

  36 months

Secondary Outcomes (3)

• Plaque volume (mm^3)

  36 months

• Average shear wave velocity

  36 months

• Ulceration and low-echo regions (if present)

  36 months

Study Arms (2)

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.

Other: 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.

Interventions

Cardiovascular and cerebrovascular diseases OTHER

Cardiovascular and cerebrovascular diseases

Symptomatic group

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with carotid plaque

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Blood Circulation

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Rong Wu, Dr

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rong Wu, Dr

CONTACT

+021-18917683516; wurong7111@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 25, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)