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AI-Enabled ECG Screening for Cardiovascular Disease (NOTABLE Trial)

N/A
Waitlist Available
Led By Sanjiv Shah, MD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to see if a machine learning program called Tempus Next can help identify heart problems in patients using their ECG results. The study will also look at how safe and effective this program is

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves the use of an AI-based screening tool rather than medication, there are no direct side effects to patients. However, there may be implications for patient care based on the algorithm's accuracy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of new CV diagnoses at 6 months
Secondary study objectives
Rate of CV outcomes at 6 months
Rate of new CV therapies at 6 months

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Care teams randomized to the intervention will have access to the AI-enabled ECG-based screening tool.
Group II: ControlActive Control1 Intervention
Care teams randomized to control will continue routine practice without access to the AI-enabled ECG-based screening tool.

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Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,640 Previous Clinical Trials
956,572 Total Patients Enrolled
7 Trials studying Atrial Fibrillation
1,547 Patients Enrolled for Atrial Fibrillation
Sanjiv Shah, MDPrincipal InvestigatorNorthwestern University
10 Previous Clinical Trials
3,019 Total Patients Enrolled
~667 spots leftby Aug 2025
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