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AI-Guided Atrial Fibrillation Detection After Ischemic Stroke: Prospective Randomized Trial

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Summary

NIH registered a prospective randomized trial (NCT07540065) comparing AI-guided atrial fibrillation risk stratification plus intensified rhythm monitoring (wearable devices, extended ECG patches) against standard care in post-ischemic stroke patients. The trial enrolls an Active Follow-up Group and a Standard Follow-up Group, with conditions including Atrial Fibrillation, Stroke, and Artificial Intelligence. The primary hypothesis is that AI-assisted ECG analysis will significantly increase AF detection rates and enable earlier anticoagulation decisions while reducing unnecessary bleeding risk exposure.

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What changed

NIH registered a new prospective randomized clinical trial on ClinicalTrials.gov. The trial investigates whether an AI-guided AF risk stratification approach combined with intensified rhythm monitoring using wearable devices and extended ECG patches increases AF detection rates compared with standard care in patients who have experienced an ischemic stroke.

Affected parties include healthcare providers managing post-stroke care, patients at risk of occult atrial fibrillation, and institutions conducting or referencing this trial for clinical decision-making. The study's findings, once available, may inform the integration of AI-assisted ECG analysis into routine post-stroke care pathways and anticoagulation prescribing practices.

Archived snapshot

Apr 20, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

AI-Assisted Workflow for Occult Atrial Fibrillation Detection After Ischemic Stroke: A Prospective Randomized Trial

N/A NCT07540065 Kind: NA Apr 20, 2026

Abstract

We hypothesize that an AI-guided AF risk stratification approach, particularly when combined with intensified rhythm monitoring using wearable devices and extended ECG patches, will significantly increase AF detection rates compared with standard care. By enabling earlier identification of patients who may benefit from anticoagulation therapy, this strategy has the potential to improve clinical outcomes while minimizing unnecessary exposure to anticoagulant-related bleeding risks. Ultimately, this trial seeks to provide robust clinical evidence supporting the integration of AI-assisted ECG analysis into routine post-stroke care, advancing precision medicine and optimizing resource allocation for patients with ischemic stroke.

Conditions: Atrial Fibrillation, Stroke, Artificial Intelligence

Interventions: Active Follow-up Group, Standard Follow-up Group

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Last updated

Classification

Agency
NIH
Published
April 20th, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07540065

Who this affects

Applies to
Healthcare providers Patients
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trial design AI-assisted diagnosis Rhythm monitoring
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Pharmaceuticals Medical Devices

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