Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06648239
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-16
Brief Title:
CCTA to Optimize Diagnostic Yield of Invasive Angiography with AI
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Coronary Computed Tomographic Angiography to Optimize Diagnostic Yield of Invasive Angiography for Low-risk Patients Screened with Artificial Intelligence
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CarDIA-AI
Brief Summary:
Coronary artery disease CAD is a leading cause of death The gold-standard test used to diagnose CAD is invasive coronary angiography ICA However nearly half the patients who receive ICA are found to have no disease or non-significant disease This means that while they receive a diagnosis they do not receive any therapeutic benefit This is concerning because ICA is expensive and it carries a risk to patients A non-invasive diagnostic test cardiac computed tomographic angiography CCTA has been shown to be as effective as ICA at diagnosing CAD in the right patient population while being less expensive and less risky for patients An optimal solution would involve screening to identify which patients are good candidates for CCTA vs which should receive ICA This screening tool could be used in a triage pathway to ensure that every patient gets the test that is best for them The investigators have used Artificial Intelligence AI to develop a model for determining which patients should receive ICA vs which should receive CCTA The investigators have also developed a triage pathway to direct patients to the most appropriate test The investigators now plan to evaluate the AI tool combined with the triage pathway through a clinical trial at Hamilton Health Sciences and Niagara Health This model of care will reduce risk to patients reduce wait times for ICA and reduce costs to the health care system
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None