Precision Medicine in Ischemic Stroke and Atrial Fibrillation

NCT ID: NCT04637087

Last Updated: 2025-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

805 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-11

Study Completion Date

2024-07-14

Brief Summary

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The overall goal of this study is to minimize morbidity due to Atrial Fibrillation (AF). The specific objective is to develop and implement a rational and personalized approach to AF risk estimation that can inform management decisions with ischemic stroke. The investigators propose to develop a clinical AF risk estimation tool in the electronic health record and to test the effectiveness of implementing a clinical AF risk estimation tool into care for use by stroke neurologists during the care of acute ischemic stroke patients at Massachusetts General Hospital. The investigators will evaluate cardiac monitoring utilization calibrated to AF risk by stroke neurologists using a custom electronic health record (EHR) notification module.

The investigators hypothesize that cardiac rhythm monitoring utilization will be positively correlated with the predicted risk of AF.

Detailed Description

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Conditions

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Atrial Fibrillation Ischemic Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Atrial Fibrillation Risk Estimation Tool

For eligible patients presenting with an acute ischemic stroke, a clinical atrial fibrillation risk estimation tool will be displayed in the patient's electronic health record through a best practice alert (BPA). The alert will display for the stroke neurologist caring for the patient when they first open the patient's chart. The neurologist may accept the automatically generated atrial fibrillation risk score displayed in the BPA, may modify some of the inputs of the score based on the patient's personal medical history and re-calculate, or may choose to dismiss the BPA.

Group Type EXPERIMENTAL

Atrial fibrillation risk electronic health record alert

Intervention Type OTHER

Electronic health record best practice alert which displays patient's 5-year risk of developing atrial fibrillation

Interventions

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Atrial fibrillation risk electronic health record alert

Electronic health record best practice alert which displays patient's 5-year risk of developing atrial fibrillation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients aged 18 years or older
* Presenting with a primary diagnosis of ischemic stroke or transient ischemic attack admitted to Massachusetts General Hospital inpatient stroke service
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston University

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Christopher D. Anderson, MD, MMSc

Division Chief

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christopher D Anderson, MD, MMSc

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Ashburner JM, Tack RWP, Khurshid S, Turner AC, Atlas SJ, Singer DE, Ellinor PT, Benjamin EJ, Trinquart L, Lubitz SA, Anderson CD. Impact of a clinical atrial fibrillation risk estimation tool on cardiac rhythm monitor utilization following acute ischemic stroke: A prepost clinical trial. Am Heart J. 2025 Jun;284:57-66. doi: 10.1016/j.ahj.2025.02.010. Epub 2025 Feb 18.

Reference Type DERIVED
PMID: 39978665 (View on PubMed)

Other Identifiers

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2020P001382

Identifier Type: -

Identifier Source: org_study_id

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