NOrthwestern Tempus AI-enaBLed Electrocardiography (NOTABLE) Trial

Not Applicable

Not yet recruiting

• Conditions: Arrhythmia; Cardiovascular Diseases; Atrial Fibrillation; Valvular Disease
• Interventions: Other: TEMPUS AI-enabled ECG-based Screening Tool

• Registration Number: NCT06511505
• Lead Sponsor: Northwestern University

Brief Summary

The goal of this clinical trial is to determine if a machine learning/artificial intelligence (AI)-based electrocardiogram (ECG) algorithm (Tempus Next software) can identify undiagnosed cardiovascular disease in patients. It will also examine the safety and effectiveness of using this AI-based tool in a clinical setting. The main questions it aims to answer are:

1. Can the AI-based ECG algorithm improve the detection of atrial fibrillation and structural heart disease?

2. How does the use of this algorithm affect clinical decision-making and patient outcomes? Researchers will compare the outcomes of healthcare providers who receive the AI-based ECG results to those who do not.

Participants (healthcare providers) will:

Be randomized into two groups: one that receives AI-based ECG results and one that does not.

In the intervention group, receive an assessment of their patient's risk of atrial fibrillation or structural heart disease with each ordered ECG.

Decide whether to perform further clinical evaluation based on the AI-generated risk assessment as part of routine clinical care.

Detailed Description

There is a large burden of undiagnosed, treatable cardiovascular disease (CVD), encompassing various heart conditions such as arrhythmias (e.g., atrial fibrillation) and structural heart diseases (e.g., valvular disease). Early detection and accurate diagnosis can significantly improve patient outcomes by enabling timely, guideline-based interventions or therapies.

The goal of this study is to leverage machine learning approaches to enhance the detection and diagnosis of CVD. By identifying patients at risk of undiagnosed CVD and referring them for further clinical evaluation, we aim to improve health outcomes.

Study Overview:

The NOTABLE study will compare the rates of new disease diagnoses, therapeutic interventions, and cardiovascular outcomes between two groups of patients managed by clinicians at Northwestern Medicine:

Patients whose clinicians use ECG predictive models. Patients whose clinicians do not use ECG predictive models.

Intervention Details:

This study utilizes the Tempus Next software, which includes AI algorithms for analyzing 12-lead ECGs. Clinicians randomized to the intervention group will automatically receive an ECG with "Risk-Based Assessment for Cardiac Dysfunction" when ordering a 12-lead ECG within EPIC during the study period. If a high-risk result is identified, clinicians will receive an EHR inbox message recommending a follow-up diagnostic test, such as echocardiography and/or ambulatory ECG monitoring.

Outcome Tracking:

A monthly report will track and provide data on:

The proportion of patients with a high-risk result. The proportion of patients receiving the follow-up diagnostic test. The proportion of patients receiving guideline-recommended therapies. This report will be sent to the study participants and clinicians randomized to the intervention group. Clinicians in the usual care group will not receive any communication from the study investigators.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-16
• Study First Submitted QC: 2024-07-16
• Last Update Submitted: 2024-07-16
• Study First Posted: 2024-07-22
• Last Update Posted: 2024-07-22
• Study Start: 2024-08-03
• Primary Completion: 2025-08-03
• Study Completion: 2026-02-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. Atrial fibrillation algorithm

   1. Age 65 or over
   2. ECG obtained as part of routine clinical care

2. Structural heart disease algorithm

   1. Age 40 or over
   2. ECG obtained as part of routine clinical care

Exclusion Criteria

1. Atrial fibrillation algorithm

   1. No history of AF
   2. No permanent pacemaker (PPM) or implantable cardioverter defibrillator (ICD)
   3. No recent cardiac surgery (within the preceding 30 days)

2. Structural heart disease algorithm

   1. No history of SHD
   2. No echocardiogram within the past 1 year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	TEMPUS AI-enabled ECG-based Screening Tool	Care teams randomized to the intervention will have access to the AI-enabled ECG-based screening tool.

Primary Outcome Measures

Name	Time	Method
Rate of new CV diagnoses at 6 months	6 months	Rate of new CV diagnoses will be defined for each predictive model and a composite of all models, and comparisons will be made between intervention and control groups.; AF: New AF diagnosis SHD: New diagnosis of moderate or severe aortic stenosis, aortic regurgitation, or mitral stenosis, new diagnosis of severe mitral regurgitation or tricuspid regurgitation, new diagnosis of LVEF ≤40%, new diagnosis of significant left ventricular hypertrophy (IVSd \>15 mm).

Secondary Outcome Measures

Name	Time	Method
Rate of new CV therapies at 6 months	6 months	Rate of new CV therapies will be evaluated for each predictive model and a composite of all models, comparisons will be made between intervention and control groups.; AF: antiarrhythmic use, AV nodal blocking agent use, anticoagulation use, AF ablation procedure SHD: new use of medication for LV systolic dysfunction (beta blockers, ACE-I/ARB/ARNI, MRA, SGLT2-I), new therapies for valvular heart disease (valve repair or replacement), new therapies for HCM, cardiac amyloidosis, hypertensive heart disease.
Rate of CV outcomes at 6 months	6 months	Rate of CV outcomes including CV death, MI, and hospitalization for a cardiovascular cause (including heart failure and stroke) between intervention and control groups.

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States