Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-01-02 @ 3:19 PM
Study NCT ID:
NCT07133451
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-21
First Post:
2025-08-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multimodal Imaging Evaluation of Vulnerability of Atherosclerotic Plaques: A Comparison of HR-VWI, OCT, and RWS
Sponsor:
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Organization:
Study Overview
Official Title:
Prospective Cohort Registry Study on Multimodal Imaging Evaluation of Vulnerability of Intracranial and Extracranial Atherosclerotic Plaques: A Comparison of HR-VWI, OCT, and RWS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
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:
The primary objective of this study is to evaluate the vulnerability of intracranial and extracranial atherosclerotic plaques using HR-VWI, OCT, and RWS technologies, while exploring correlations among these three imaging techniques. Secondary objectives include: 1) Investigating the relationship between RWS and plaque progression and identifying optimal RWS predictors; 2) Further evaluating the clinical value of RWS and HR-VWI in stroke prediction through two-year clinical and HR-VWI follow-up evaluations.
Detailed Description:
Intracranial atherosclerotic stenosis (ICAS) is one of the leading causes of ischemic cerebrovascular disease worldwide, with an incidence rate as high as 46.6% among ischemic stroke or transient ischemic attacks (TIA) patients in China. Traditional arterial imaging techniques such as computed tomography angiography (CTA), magnetic resonance angiography (MRA), and digital subtraction angiography (DSA) all provide lumen imaging capabilities. However, these methods can only reflect the severity of atherosclerotic lesions through vascular narrowing, failing to accurately assess the condition of the vessel wall.
High resolution magnetic resonance vessel wall imaging (HR-VWI) has enabled 2D and 3D imaging of intracranial arterial walls. This technique not only provides clear visualization of vascular morphology and signal characteristics, but also identifies plaque components, enhancement intensity, reconstruction type and load by suppressing intravascular blood flow. It also evaluates ICAS-prone plaque features such as intraplaque hemorrhage (IPH), lipid-rich necrotic core (LRNC), and others. However, current HR-VWI scans face challenges including prolonged examination time, difficulties in aligning multiple sequences, and numerous contraindications (e.g., claustrophobia and pacemaker implantation). Additionally, image quality and effectiveness of intracranial artery HR-VWI are influenced by hardware/software parameters like magnetic field strength, receiving coils, imaging dimensions, sequences, and spatial resolution. These factors lead to variations across hospitals, with the absence of standardized protocols hindering standardized interpretation and analysis of images.
Optical Coherence Tomography (OCT), as an intravascular imaging technique, demonstrates high sensitivity and specificity in identifying different plaque components. With image resolution reaching 10μm - ten times that of conventional intravascular ultrasound- it has gained widespread recognition in coronary artery diagnosis and treatment. In recent years, OCT has also been applied in cerebral vascular interventional therapy, achieving notable progress in evaluating cerebral atherosclerotic plaques, performing interventional procedures, and conducting long-term follow-up studies.
Blood vessels are constantly subjected to biomechanical forces in the human body, including intraluminal arterial pressure and blood flow resistance. These mechanical forces induce dynamic strain and stress on vascular walls, which can trigger the rupture of atherosclerotic fibrous caps and inflammatory-prone plaques. High-resolution angiography can capture plaque strain or stress. Radial Wall Strain (RWS), a novel technique that utilizes high-resolution angiographic images and artificial intelligence to calculate plaque strain based on deformation patterns during different cardiac phases, has proven effective in coronary artery research. It demonstrates significant potential for risk stratification and prognosis prediction. Validation studies using OCT-defined plaque characteristics revealed that RWSmax shows a significant positive correlation with plaque lipid load and the lipid-fibrous cap ratio, while showing a significant negative correlation with cap thickness. A clinical cohort study employing propensity score matching evaluated the predictive power of angiography-based RWS for acute myocardial infarction (AMI) risk in newly diagnosed patients with mild-to-moderate coronary stenosis. Results indicated that RWSmax\> 12% significantly increased the risk of AMI in untreated lesions by 7.25. Another study analyzed 1,318 delayed revascularization (DRV) vessels reported in the FAVOR III China main study. Vessels with RWSmax\> 12% showed a 1-year vascular-derived composite endpoint event risk of 14.3%, compared to 2.9% for those ≤12% (risk ratio: 4.44). The research supports applying the novel RWS technology to assess residual risk in non-ischemic vessels defined by quantitative flow ratio (QFR), guiding necessary interventions such as intensified pharmacotherapy to enhance DRV safety. These findings indicate that RWS offers a novel decision-making model for coronary risk assessment and optimized management. Importantly, RWS can be calculated using routine single-slice angiographic images, eliminating the need for additional invasive procedures and demonstrating broad clinical applicability. However, its value in evaluating intracranial unstable plaques and their progression remains unverified. To address these technical advantages, this prospective clinical study aims to investigate RWS's efficacy in assessing intracranial plaque stability and progression risks, while comparing it with OCT and HR-VWI methods to evaluate feasibility and effectiveness.
High resolution magnetic resonance vessel wall imaging (HR-VWI) has enabled 2D and 3D imaging of intracranial arterial walls. This technique not only provides clear visualization of vascular morphology and signal characteristics, but also identifies plaque components, enhancement intensity, reconstruction type and load by suppressing intravascular blood flow. It also evaluates ICAS-prone plaque features such as intraplaque hemorrhage (IPH), lipid-rich necrotic core (LRNC), and others. However, current HR-VWI scans face challenges including prolonged examination time, difficulties in aligning multiple sequences, and numerous contraindications (e.g., claustrophobia and pacemaker implantation). Additionally, image quality and effectiveness of intracranial artery HR-VWI are influenced by hardware/software parameters like magnetic field strength, receiving coils, imaging dimensions, sequences, and spatial resolution. These factors lead to variations across hospitals, with the absence of standardized protocols hindering standardized interpretation and analysis of images.
Optical Coherence Tomography (OCT), as an intravascular imaging technique, demonstrates high sensitivity and specificity in identifying different plaque components. With image resolution reaching 10μm - ten times that of conventional intravascular ultrasound- it has gained widespread recognition in coronary artery diagnosis and treatment. In recent years, OCT has also been applied in cerebral vascular interventional therapy, achieving notable progress in evaluating cerebral atherosclerotic plaques, performing interventional procedures, and conducting long-term follow-up studies.
Blood vessels are constantly subjected to biomechanical forces in the human body, including intraluminal arterial pressure and blood flow resistance. These mechanical forces induce dynamic strain and stress on vascular walls, which can trigger the rupture of atherosclerotic fibrous caps and inflammatory-prone plaques. High-resolution angiography can capture plaque strain or stress. Radial Wall Strain (RWS), a novel technique that utilizes high-resolution angiographic images and artificial intelligence to calculate plaque strain based on deformation patterns during different cardiac phases, has proven effective in coronary artery research. It demonstrates significant potential for risk stratification and prognosis prediction. Validation studies using OCT-defined plaque characteristics revealed that RWSmax shows a significant positive correlation with plaque lipid load and the lipid-fibrous cap ratio, while showing a significant negative correlation with cap thickness. A clinical cohort study employing propensity score matching evaluated the predictive power of angiography-based RWS for acute myocardial infarction (AMI) risk in newly diagnosed patients with mild-to-moderate coronary stenosis. Results indicated that RWSmax\> 12% significantly increased the risk of AMI in untreated lesions by 7.25. Another study analyzed 1,318 delayed revascularization (DRV) vessels reported in the FAVOR III China main study. Vessels with RWSmax\> 12% showed a 1-year vascular-derived composite endpoint event risk of 14.3%, compared to 2.9% for those ≤12% (risk ratio: 4.44). The research supports applying the novel RWS technology to assess residual risk in non-ischemic vessels defined by quantitative flow ratio (QFR), guiding necessary interventions such as intensified pharmacotherapy to enhance DRV safety. These findings indicate that RWS offers a novel decision-making model for coronary risk assessment and optimized management. Importantly, RWS can be calculated using routine single-slice angiographic images, eliminating the need for additional invasive procedures and demonstrating broad clinical applicability. However, its value in evaluating intracranial unstable plaques and their progression remains unverified. To address these technical advantages, this prospective clinical study aims to investigate RWS's efficacy in assessing intracranial plaque stability and progression risks, while comparing it with OCT and HR-VWI methods to evaluate feasibility and effectiveness.
Study Oversight
Has Oversight DMC:
True
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?: