Ignite Creation Date:
2024-07-17 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06473272
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-04
Brief Title:
Evaluation of Vulnerability of Carotid Artery Plaques and Prediction of Cardio-Cerebrovascular Event Risk Using Ultrasonic Imaging
Sponsor:
Shanghai General Hospital Shanghai Jiao Tong University School of Medicine
Organization:
Shanghai General Hospital Shanghai Jiao Tong University School of Medicine
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients39 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 patients39 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
This study is a prospective multi-center cohort study that aims to collect 600 patients with carotid artery plaques including over 66000 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 15 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
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
This study is a prospective multi-center cohort study that aims to collect 600 patients with carotid artery plaques including over 66000 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 15 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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None