NOrthwestern Tempus AI-enaBLed Electrocardiography (NOTABLE) Trial: A Pragmatic, Real-world Study of an Artificial-intelligence Enabled Electrocardiogram Algorithms to Improve the Diagnosis of Cardiovascular Disease
Northwestern University
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.
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 impro…
Eligibility
- Age range
- 40+ years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- OtherTEMPUS AI-enabled ECG-based Screening Tool
The AI-enabled ECG-based screening tool, Tempus Next software, analyzes 12-lead ECG recordings to identify patients at increased risk for undiagnosed cardiovascular diseases, specifically atrial fibrillation (AF) and structural heart disease (SHD). Clinicians in the intervention group will receive a risk assessment for AF and SHD each time they order an ECG for their patients.
Location
- Northwestern UniversityChicago, Illinois