Precision Medicine in Ischemic Stroke and Atrial Fibrillation

NCT04637087 | Completed

• 1 other identifier: 2020P001382
• Study Type: interventional
• Target: 805
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation; Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Incidence of cardiac rhythm monitoring

  Incidence of any cardiac rhythm monitoring in the 6-month follow-up period following discharge for an acute ischemic stroke. Cardiac rhythm monitoring will be ascertained based on electronic health record documentation.

  6-months

Secondary Outcomes (8)

• Proportion of patients with implantable loop recorder orders

  12-months

• Proportion of patients with ambulatory wearable cardiac rhythm monitoring orders

  12-months

• Proportion of patients with cardiac monitor ordered by neurologist

  1-month

• Proportion of patients with a new atrial fibrillation diagnosis

  12-months

• Proportion of patients with recurrent stroke

  12-months

Study Arms (1)

Atrial Fibrillation Risk Estimation Tool

EXPERIMENTAL

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.

Other: Atrial fibrillation risk electronic health record alert

Interventions

Atrial fibrillation risk electronic health record alert OTHER

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

Atrial Fibrillation Risk Estimation Tool

Eligibility Criteria

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

You may qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Boston University: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 39978665 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Ischemic Stroke

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Christopher D Anderson, MD, MMSc

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Chief

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: November 19, 2020
• Study Start: March 11, 2021
• Primary Completion: March 10, 2022
• Study Completion: July 14, 2024
• Last Updated: May 7, 2025

Record last verified: 2024-05

Locations

US (1)