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AF Risk EHR Alert for Ischemic Stroke (PreMISe-AF Trial)

N/A
Waitlist Available
Led By Steven A Lubitz, MD, MPH
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-months
Awards & highlights
No Placebo-Only Group

Summary

This trial will develop and test a clinical AF risk estimation tool to help inform management decisions with ischemic stroke patients. The hypothesis is that cardiac monitoring utilization will be positively correlated with the predicted risk of AF.

Who is the study for?
This trial is for adults 18 or older who have had an ischemic stroke or transient ischemic attack and are admitted to the Massachusetts General Hospital inpatient stroke service. It's not open to those who don't meet these specific conditions.
What is being tested?
The study aims to develop a tool that predicts atrial fibrillation (AF) risk, integrated into the electronic health record system. It will test if this tool helps doctors decide on heart monitoring for stroke patients based on their AF risk.
What are the potential side effects?
Since this trial involves using an electronic alert system rather than medication, there are no direct side effects from interventions like drugs. However, changes in patient management could indirectly affect outcomes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 or older and was diagnosed with a stroke or mini-stroke at Massachusetts General Hospital.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-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
Incidence of cardiac rhythm monitoring
Secondary study objectives
Proportion of patients deceased
Proportion of patients with a new atrial fibrillation diagnosis
Proportion of patients with ambulatory wearable cardiac rhythm monitoring orders
+5 more

Awards & Highlights

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Atrial Fibrillation Risk Estimation ToolExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,014 Previous Clinical Trials
13,307,931 Total Patients Enrolled
15 Trials studying Atrial Fibrillation
64,183 Patients Enrolled for Atrial Fibrillation
Boston UniversityOTHER
472 Previous Clinical Trials
9,986,326 Total Patients Enrolled
3 Trials studying Atrial Fibrillation
513 Patients Enrolled for Atrial Fibrillation
Steven A Lubitz, MD, MPHPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
2,336 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
2,336 Patients Enrolled for Atrial Fibrillation
~321 spots leftby Nov 2025