Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06637293
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-09
Brief Title:
Deployment and Evaluation of Artificial Intelligence Software for Electrocardiogram Analysis and Management in Primary Care
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Deployment and Evaluation of Artificial Intelligence Software for Electrocardiogram Analysis and Management in Primary Care
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:
DAISEA-ECG
Brief Summary:
The DAISEA-ECG project aims to improve the diagnosis of heart diseases in primary care through the DeepECG platform which combines ECG-AI and ECHONeXT algorithms This study uses a stepped wedge design where each Family Medicine Group acts as its own control The FMGs will gradually transition from the control period without AI recommendations to the intervention period with AI recommendations activated in a randomized sequence
The primary objective is to compare the sensitivity of family physicians in detecting cardiac pathologies with and without the assistance of the DeepECG platform Sensitivity is defined as the proportion of patients correctly referred to cardiology or for transthoracic echocardiography TTE among those who indeed required cardiovascular evaluation as confirmed by an independent adjudication committee
The primary objective is to compare the sensitivity of family physicians in detecting cardiac pathologies with and without the assistance of the DeepECG platform Sensitivity is defined as the proportion of patients correctly referred to cardiology or for transthoracic echocardiography TTE among those who indeed required cardiovascular evaluation as confirmed by an independent adjudication committee
Detailed Description:
Mathematically sensitivity is calculated as True Positive True Positive False Negative where True Positive represents correctly referred patients and false negatives represents patients who should have been referred but were not
The secondary objectives include determining the rate of cardiovascular evaluation referrals before and after the intervention implementation of the DeepECG platform the individual characteristics of the intervention PPV NPV and specificity as well as evaluating the feasibility of implementing AI-based automatic ECG interpretation in primary care through surveys of family physicians and cardiologists
PPV Positive predictive value NPV Negative predictive value
The secondary objectives include determining the rate of cardiovascular evaluation referrals before and after the intervention implementation of the DeepECG platform the individual characteristics of the intervention PPV NPV and specificity as well as evaluating the feasibility of implementing AI-based automatic ECG interpretation in primary care through surveys of family physicians and cardiologists
PPV Positive predictive value NPV Negative predictive value
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