Ignite Creation Date:
2024-07-17 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06462989
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-06-12
Brief Title:
Harnessing ECG Artificial Intelligence for Rapid Treatment and Accurate Interpretation an Open Label Randomized Controlled Trial
Sponsor:
Montreal Heart Institute
Organization:
Montreal Heart Institute
Study Overview
Official Title:
Harnessing ECG Artificial Intelligence for Rapid Treatment and Accurate Interpretation an Open Label Randomized Controlled Trial
Status:
NOT_YET_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:
HEART-AI
Brief Summary:
The HEART-AI Harnessing ECG Artificial Intelligence for Rapid Treatment and Accurate Interpretation is an open-label single-center randomized controlled trial that aims to deploy a platform called DeepECG at point-of-care for AI-analysis of 12-lead ECGs The platform will be tested among healthcare professionals medical students residents doctors nurse practitioners who read 12-lead ECGs In the intervention group the platform will display the ECHONeXT structural heart disease SHD scores in randomized patients to help doctors prioritize TTEs Supplemental Table 2 Figure 1 Also this platform will display the DeepECG-AI interpretation which detects problems such as ischemic conditions arrhythmias or chamber enlargements and acts an improved alternative to commercially available ECG interpretation systems such as MUSE Supplemental Table 1 The performance for both of these models is presented in supplemental appendix Supplemental Table 1 Supplemental Table 2 Supplemental Figure 1
Our primary objective is to assess the impact of displaying the ECHONeXT interpretation on 12-lead ECGs specifically focusing on the detection rates of Structural Heart Disease SHD on TTE among newly referred patients at MHI and on the delay between the time of the first ECG opened in the platform and the TTE evaluation among newly referred patients at MHI at high or intermediate risk of SHD by comparing patients in the intervention ECHONeXT prediction of SHD displayed and recommendation on the priority to assign to the TTE arm and patients in the control ECHONeXT prediction and recommendation hidden arm The main secondary objective is to evaluate the proportion of ECGs where the users agree with the DeepECG diagnosis across all ECGs accessed by the user of the platform By integrating an AI-analysis platform at the point of care and evaluating its impact on ECG interpretation accuracy and prioritization of incremental tests the HEART-AI study aims to provide valuable insights into the potential of AI in improving cardiac care and patient outcomes
Our primary objective is to assess the impact of displaying the ECHONeXT interpretation on 12-lead ECGs specifically focusing on the detection rates of Structural Heart Disease SHD on TTE among newly referred patients at MHI and on the delay between the time of the first ECG opened in the platform and the TTE evaluation among newly referred patients at MHI at high or intermediate risk of SHD by comparing patients in the intervention ECHONeXT prediction of SHD displayed and recommendation on the priority to assign to the TTE arm and patients in the control ECHONeXT prediction and recommendation hidden arm The main secondary objective is to evaluate the proportion of ECGs where the users agree with the DeepECG diagnosis across all ECGs accessed by the user of the platform By integrating an AI-analysis platform at the point of care and evaluating its impact on ECG interpretation accuracy and prioritization of incremental tests the HEART-AI study aims to provide valuable insights into the potential of AI in improving cardiac care and patient outcomes
Detailed Description:
The HEART-AI Harnessing ECG Artificial Intelligence for Rapid Treatment and Accurate Interpretation study primarily aims to assess the effect of displaying the ECHONeXT interpretation on the rate of Structural Heart Disease SHD diagnosis on Transthoracic Echocardiograms TTEs and the time between a first ECG and TTE in newly referred patients to MHI We will achieve this by comparing the diagnostic outcomes and time between the first ECG and TTE between the intervention group where the ECHONeXT interpretation is displayed to users and the control group where it is not displayed thereby quantifying the influence of AI-supported diagnostics on clinical decision-making and patient management strategies Table 1
For the purpose of the study SHD will be defined as presence of any of the following on TTE
LVEF 45
Mild moderate or severe RV Dysfunction
The presence of one or multiple valvulopathies in this list
Moderate-to-severe pulmonary regurgitation
Moderate-to-severe tricuspid regurgitation
Moderate-to-severe mitral regurgitation
Moderate-to-severe aortic regurgitation
Moderate-to-severe aortic stenosis
Moderate or severe pericardial effusion Tamponade or any effusion 1 cm
LV wall thickness 13 cm
Apical cardiomyopathy
Pulmonary hypertension as defined using the systolic pressure of the pulmonary artery greater or equal to 25 mm Hg on TTE
For the purpose of the study SHD will be defined as presence of any of the following on TTE
LVEF 45
Mild moderate or severe RV Dysfunction
The presence of one or multiple valvulopathies in this list
Moderate-to-severe pulmonary regurgitation
Moderate-to-severe tricuspid regurgitation
Moderate-to-severe mitral regurgitation
Moderate-to-severe aortic regurgitation
Moderate-to-severe aortic stenosis
Moderate or severe pericardial effusion Tamponade or any effusion 1 cm
LV wall thickness 13 cm
Apical cardiomyopathy
Pulmonary hypertension as defined using the systolic pressure of the pulmonary artery greater or equal to 25 mm Hg on TTE
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