Ignite Creation Date:
2024-05-06 @ 6:42 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05750082
Status:
RECRUITING
Last Update Posted:
2023-04-19
First Post:
2022-11-08
Brief Title:
The AIPLAQUE Study An Artificial Intelligence-based Prospective Study to Analyze PLAQUE Using CCTA
Sponsor:
Harbin Medical University
Organization:
Harbin Medical University
Study Overview
Official Title:
Automated Plaque Characterization and Functional Analysis of Coronary CTA Based on OCT Images Using Artificial Intelligence
Status:
RECRUITING
Status Verified Date:
2023-04
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 trial is a single-center prospective observational clinical study All patients who have at least one coronary artery stenosis of 30-90 in diameter 2mm confirmed by CCTA and who are scheduled to undergo clinically indicated invasive coronary angiography ICA and optical coherence tomography OCT evaluation andor treatment will be eligible for enrollment We proposed a novel approach that integrates CCTA ICA and OCT images to automatically measure plaque characterization and calculate CT-FFR using computational fluid dynamics CFD simulation and artificial intelligence deep learning
Detailed Description:
Acute coronary syndrome ACS is one of the leading causes of coronary artery disease CAD death worldwide Vulnerable plaque rupture is a primary underlying cause of luminal thrombosis responsible for provoking ACS Therefore identifying high-risk plaques before ACS occurs has been a major research goal and requires further clinical perspectives Coronary computed tomography angiography CCTA is a comprehensive non-invasive and cost-effective imaging assessment approach which can provide the ability to identify the characteristics and morphology of high-risk atherosclerotic plaques associated with ACS Optical coherence tomography OCT is a new light-based intravascular imaging technique that provides high-resolution cross-sectional images of coronary artery anatomy Due to its superior resolution OCT is more accurate in measuring the sites of plaque vulnerability distinguishing the differences in its composition informing about the anatomic severity of epicardial stenoses and also provides input for computational models to assess functional severity
The objectives of the study are 1 To construct an artificial intelligence model for identifying coronary plaque components on CTA images using OCT as the reference standard 2 To conduct fluid mechanics simulation including blood vessel wall and plaque by using geometric and physiological models of blood vessels and plaques and to provide more accurate functional parameters CT-FFR
The enrollment criteria will be 1 Patients who presented with stable angina pectoris or acute coronary syndrome 2 patients who meet the indications for coronary CT angiography percutaneous coronary angiography and intravascular imaging 3 Among those patients patients who have at least one coronary artery stenosis of 30 - 90 in diameter 2mm confirmed by CCTA
Data collected will include CCTA full angiographic and OCT images Combined with CTAICAOCT images of multiple modalities this study will develop a novel images analysis technology to automatically extract vascular lumen plaque characterization fluid-solid mechanical properties and myocardial ischemia conditions using computational fluid dynamics CFD simulation and artificial intelligence deep learning
The objectives of the study are 1 To construct an artificial intelligence model for identifying coronary plaque components on CTA images using OCT as the reference standard 2 To conduct fluid mechanics simulation including blood vessel wall and plaque by using geometric and physiological models of blood vessels and plaques and to provide more accurate functional parameters CT-FFR
The enrollment criteria will be 1 Patients who presented with stable angina pectoris or acute coronary syndrome 2 patients who meet the indications for coronary CT angiography percutaneous coronary angiography and intravascular imaging 3 Among those patients patients who have at least one coronary artery stenosis of 30 - 90 in diameter 2mm confirmed by CCTA
Data collected will include CCTA full angiographic and OCT images Combined with CTAICAOCT images of multiple modalities this study will develop a novel images analysis technology to automatically extract vascular lumen plaque characterization fluid-solid mechanical properties and myocardial ischemia conditions using computational fluid dynamics CFD simulation and artificial intelligence deep learning
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