NOrthwestern Tempus AI-enaBLed Electrocardiography (NOTABLE) Trial
Sponsored by Northwestern University
About this study
The goal of this clinical trial is to determine if a machine learning/artificial intelligence (AI)-based electrocardiogram (ECG) algorithm (rECHOmmend and ECG-AF) 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.
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, the study aims 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 m…
Where this study is enrolling
- I'm interested
Northwestern University
Chicago, Illinois
Who can participate
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
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.