NCT06511505 NOrthwestern Tempus AI-enaBLed Electrocardiography (NOTABLE) Trial
| NCT ID | NCT06511505 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northwestern University |
| Condition | Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2024-09-16 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,000 participants in total. It began in 2024-09-16 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Sanjiv Shah, MD
PRINCIPAL INVESTIGATOR
Northwestern University
Frequently Asked Questions
Who can join the NCT06511505 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06511505 currently recruiting?
Yes, NCT06511505 is actively recruiting participants. Visit ClinicalTrials.gov or contact Northwestern University to inquire about joining.
Where is the NCT06511505 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT06511505 clinical trial?
NCT06511505 is sponsored by Northwestern University. The principal investigator is Sanjiv Shah, MD at Northwestern University. The trial plans to enroll 1,000 participants.
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