AI-Enabled ECG Screening for Cardiovascular Disease

(NOTABLE Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: No AF, No PPM/ICD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates whether the TEMPUS AI-enabled ECG-based Screening Tool can detect heart issues like atrial fibrillation (irregular heartbeat) and structural heart disease (problems with the heart's structure) using ECGs (heart activity tests). The researchers aim to determine if the AI tool aids doctors in making better decisions and improving patient care. The trial includes two groups: one will use the AI tool alongside regular tests, while the other will not. Suitable participants are those already undergoing an ECG as part of routine care and are over 40 or 65, depending on the heart issue being assessed. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance heart health diagnostics and patient care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on using an AI-based ECG tool to assess heart disease risk.

What prior data suggests that this AI-based ECG algorithm is safe for use in clinical settings?

Research has shown that the Tempus AI-enabled ECG tool is promising in spotting heart problems. The FDA has approved similar software that identifies patients at risk for low ejection fraction, a measure of heart function, indicating its safety for medical use.

However, specific information on side effects for this particular AI tool is limited in the sources provided. As a software that analyzes ECGs (tests that check heart activity), it is not expected to cause direct harm. Its purpose is to help doctors identify heart conditions more accurately.

Overall, the AI-enabled ECG tool appears well-received, with no reports of safety issues so far. It is designed to assist doctors in making better decisions about patient care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the AI-enabled ECG-based screening tool because it offers a cutting-edge approach to detecting cardiovascular disease. Unlike traditional ECGs that require expert interpretation, this tool uses artificial intelligence to analyze the data, potentially identifying issues more quickly and accurately. This can lead to faster diagnosis and treatment, improving patient outcomes. By incorporating AI, this method aims to enhance the precision and efficiency of cardiovascular screenings, making it a promising advancement in the field.

What evidence suggests that this AI-enabled ECG screening tool is effective for detecting cardiovascular disease?

Research shows that the Tempus AI-enabled ECG tool might help detect hidden heart problems like atrial fibrillation (AFib) and structural heart disease. Studies have demonstrated that this AI tool can identify patients at higher risk for AFib by analyzing regular ECGs. The FDA has approved the tool, confirming it meets certain safety and effectiveness standards. Early results suggest that using this AI tool could enable doctors to detect heart issues more quickly and accurately, potentially leading to better patient outcomes. In this trial, care teams in the intervention arm will have access to the AI-enabled ECG-based screening tool, allowing doctors to make more informed decisions about further tests or treatments. ^{4 6 7 8 9}

Who Is on the Research Team?

Sanjiv Shah, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for healthcare providers who are assessing patients with potential cardiovascular issues like atrial fibrillation or structural heart disease. Providers will be randomly assigned to either use an AI-based ECG tool in their evaluations or not.

Inclusion Criteria

I am over 40 and have had an ECG as part of my regular health checks.

I am 65 or older and have had an ECG for my heart.

Exclusion Criteria

I have never had atrial fibrillation, don't have a pacemaker or ICD, and haven't had recent heart surgery.

I have no history of heart disease and haven't had a heart ultrasound in the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Care teams randomized to the intervention will have access to the AI-enabled ECG-based screening tool

6 months

Monthly reports

Control

Care teams randomized to control will continue routine practice without access to the AI-enabled ECG-based screening tool

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• TEMPUS AI-enabled ECG-based Screening Tool

Trial Overview The NOTABLE Trial is testing whether a machine learning AI tool can help detect undiagnosed cardiovascular diseases more effectively when used alongside standard ECG tests in clinical settings.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Care teams randomized to the intervention will have access to the AI-enabled ECG-based screening tool.

Group II: Control Active Control 1 Intervention

Care teams randomized to control will continue routine practice without access to the AI-enabled ECG-based screening tool.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Published Research Related to This Trial

A study involving 44,959 patients demonstrated that an AI model applied to ECG data can effectively identify asymptomatic left ventricular dysfunction (ALVD), achieving high accuracy (85.7%) and sensitivity (86.3%).

Patients who screened positive for ALVD using the AI model were found to be four times more likely to develop future ventricular dysfunction, highlighting the potential of AI-enhanced ECG as a proactive screening tool for early intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening for cardiac contractile dysfunction using an artificial intelligence-enabled electrocardiogram. Attia, ZI., Kapa, S., Lopez-Jimenez, F., et al.[2022]

Citations

1. tempus.com tempus.com/cardiology/ecg-ai/?srsltid=AfmBOoq8QtZ0TQHt0IubL2HC4gsKYiMra7zKD2K4Hsnr0im4AjKSzU4f

ECG-AI Tempus ECG-AI devices integrate with advanced cardiology algorithms to detect signs associated with certain cardiovascular conditions and notify care teams for ...

2. tempus.com tempus.com/cardiology/?srsltid=AfmBOopuiGBL3ZRfSjdUKLTsaF2AxyY21UqipH8R_bxVGlusXJ6QmSnB

Cardiology We believe that AI-enabled solutions can help shorten the diagnostic odyssey and improve the lives and outcomes of patients with cardiovascular disease. *. I ...

3. tempus.com tempus.com/news/tempus-receives-u-s-fda-510k-clearance-for-tempus-ecg-af-an-ai-based-algorithm-that-identifies-patients-at-increased-risk-of-afib/?srsltid=AfmBOooRTD9hHWhLMRh5oHzMrmelNBy07BLuKbIux62TfBkLTWt9Aml7

Tempus Receives U.S. FDA 510(k) Clearance ... Tempus Receives U.S. FDA 510(k) Clearance for Tempus ECG-AF, an AI-based Algorithm that Identifies Patients at Increased Risk of AFib.

4. ctv.veeva.com ctv.veeva.com/study/northwestern-tempus-ai-enabled-electrocardiography-notable-trial

NOrthwestern Tempus AI-enaBLed Electrocardiography ... Study Overview: The NOTABLE study will compare the rates of new disease diagnoses, therapeutic interventions, and cardiovascular outcomes ...

5. xtalks.com xtalks.com/tempus-scores-fda-clearance-for-ai-ecg-software-to-flag-low-lvef-4329/

Tempus Scores FDA Clearance for AI ECG Software ... Tempus has won FDA clearance for its ECG-Low EF AI software, which flags patients at risk of low ejection fraction using standard ECGs.

6. tempus.com tempus.com/cardiology/ecg-ai/?srsltid=AfmBOorwBUmUfZTIWPQTm_VyYbV6hUP_gCfYmBhAsN4dtgCLm2sf_JYs

ECG-AI Tempus ECG-AI devices integrate with advanced cardiology algorithms to detect signs associated with certain cardiovascular conditions and notify care teams for ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06511505/northwestern-tempus-ai-enabled-electrocardiography-notable-trial

NOrthwestern Tempus AI-enaBLed Electrocardiography ... The goal of this clinical trial is to determine if a machine learning/artificial intelligence (AI)-based electrocardiogram (ECG) algorithm ...

8. tempus.com tempus.com/cardiology/?srsltid=AfmBOopFtrUP-NGVByc-uWRPioinhOayZoa8hDuDs5meNJ_pu4VvU8Yz

Cardiology AI-enabled solutions to help providers close care gaps for patients who may have undiagnosed and undertreated cardiovascular disease.

9. tempus.com tempus.com/life-sciences/cardiology-care-gap-solutions/?srsltid=AfmBOop_U2xHP728X2TqB7gqdpikVkm_Yw-NQH5GLJOk1NzVRfKISkvx

Cardiology Care Gap Solutions AI-enabled care pathway platform to help clinicians find patients with undiagnosed or undertreated cardiovascular or pulmonary disease.