Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06410690
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-03-25
Brief Title:
Trustworthy Integrated Artificial Intelligence Tools for Predicting High-risk CORonary PlaqueS
Sponsor:
Centro Cardiologico Monzino
Organization:
Centro Cardiologico Monzino
Study Overview
Official Title:
Rustworthy Integrated Artificial Intelligence Tools for Predicting High-risk CORonary PlaqueS
Status:
RECRUITING
Status Verified Date:
2024-03
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:
AI-CORPS
Brief Summary:
Coronary artery disease CAD is among the leading cause of death and disability Identification of patients at high risk of cardiovascular events is pivotal However current risk stratification based on imaging and known biomarkers is suboptimal The objective of this proposal is to develop a multicriteria decision model for non-invasive assessment of vulnerable atherosclerotic patients and to evaluate its ability to predict the occurrence of an adverse event in intermediate-to-high risk patients with suspected or known CAD The planned workflow includes a first step using a retrospective cohort of patients undergoing clinically indicated coronary angiography CCTA to develop an integrated application for automatic coronary artery segmentation quantitative plaque analysis biomechanics and fluid dynamics based on machine learning radiomics and computational analysis approaches and validated against the reference standard for each tool The second step will apply this new methodology to a larger retrospective cohort of patients with the integration of genomic biomarker assessment to derive the most accurate risk stratification model to properly identify vulnerable patients and vulnerable plaques with respect to outcome Finally in the third step the derived predictive model will be prospectively validated in an independent cohort of patients from an ongoing study CTP-PRO study to assess the robustness and accuracy of the proposed solution
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