Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06178900
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2023-12-14
Brief Title:
Evaluating AI-Gatekeeper Software in Coronary Artery Stenosis Screening A Multicenter RCT
Sponsor:
INFINITT Healthcare
Organization:
INFINITT Healthcare
Study Overview
Official Title:
A Prospective Multicenter Open-label Randomized Comparative Clinical Trial to Verify the Effectiveness Safety and Cost-effectiveness of AI-Gatekeeper a Multimodal AI Software in Assisting the Screening of Coronary Artery Stenosis
Status:
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:
AIGatekeeper
Brief Summary:
The purpose of this study is to determine the efficacy safety and cost-effectiveness of AI-Gatekeeper software to assist clinicians in the diagnosis of coronary artery disease by predicting coronary artery stenosis 50 from a multimodal AI technology that integrates clinical risk factors and baseline blood tests including chest X-ray electrocardiogram and echocardiogram in patients with suspected coronary artery disease coronary stenosis
Detailed Description:
Coronary artery disease CAD is a leading cause of global mortality accounting for over 50 of heart disease-related deaths Initial evaluations for CAD typically involve chest X-rays electrocardiograms ECG risk factor assessments and basic blood tests However these primary tests cant conclusively diagnose CAD When CAD is suspected coronary CTA CCTA or invasive coronary angiography ICA is performed determining the need for procedures like stenting or revascularization
Interestingly over 50 of patients undergoing CCTA or ICA dont require treatment as CAD is either absent or not severe enough This leads to unnecessary procedures and significant healthcare costs For instance in the US the cost of unnecessary ICAs reaches billions annually with similar trends in South Korea
AI-Gatekeeper software assists clinicians in diagnosing coronary artery disease by predicting coronary artery stenosis 50 using multimodal AI technology It integrates clinical risk factors and baseline blood tests including chest X-ray electrocardiogram and echocardiogram in patients with suspected coronary artery disease The purpose of this study is to determine the efficacy safety and cost-effectiveness of the AI-Gatekeeper software in a prospective multicenter randomized control trial
Interestingly over 50 of patients undergoing CCTA or ICA dont require treatment as CAD is either absent or not severe enough This leads to unnecessary procedures and significant healthcare costs For instance in the US the cost of unnecessary ICAs reaches billions annually with similar trends in South Korea
AI-Gatekeeper software assists clinicians in diagnosing coronary artery disease by predicting coronary artery stenosis 50 using multimodal AI technology It integrates clinical risk factors and baseline blood tests including chest X-ray electrocardiogram and echocardiogram in patients with suspected coronary artery disease The purpose of this study is to determine the efficacy safety and cost-effectiveness of the AI-Gatekeeper software in a prospective multicenter randomized control trial
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