NOrthwestern Tempus AI-enaBLed Electrocardiography (NOTABLE) Trial

NCT06511505 | Not Yet Recruiting FDA Device

• 1 other identifier: STU00220862
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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. 1.Can the AI-based ECG algorithm improve the detection of atrial fibrillation and structural heart disease?
2. 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.

Conditions

Atrial Fibrillation; Cardiovascular Diseases; Arrhythmia; Valvular Disease

Keywords

early detection; artificial intelligence; structural heart disease; atrial fibrillation; cardiac diagnostics

Outcome Measures

Primary Outcomes (1)

• Rate of new CV diagnoses at 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).

  6 months

Secondary Outcomes (2)

• Rate of new CV therapies at 6 months

  6 months

• Rate of CV outcomes at 6 months

  6 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: TEMPUS AI-enabled ECG-based Screening Tool

Control

NO INTERVENTION

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

Interventions

TEMPUS AI-enabled ECG-based Screening Tool OTHER

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.

Intervention

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Atrial fibrillation algorithm
• Age 65 or over
• ECG obtained as part of routine clinical care
• Structural heart disease algorithm
• Age 40 or over
• ECG obtained as part of routine clinical care

You may not qualify if:

• Atrial fibrillation algorithm
• No history of AF
• No permanent pacemaker (PPM) or implantable cardioverter defibrillator (ICD)
• No recent cardiac surgery (within the preceding 30 days)
• Structural heart disease algorithm
• No history of SHD
• No echocardiogram within the past 1 year

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Cardiovascular Diseases; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sanjiv Shah, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Institute for Artificial Intelligence in Medicine - Center for Deep Phenotyping and Precision Therapeutics

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 22, 2024
• Study Start: August 3, 2024
• Primary Completion: August 3, 2025
• Study Completion: February 3, 2026
• Last Updated: July 22, 2024

Record last verified: 2024-07

Locations

US (1)