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Precision Medicine in Ischemic Stroke and Atrial Fibrillation

Precision Medicine in Ischemic Stroke and Atrial Fibrillation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04637087
Acronym
PreMISe-AF
Enrollment
805
Registered
2020-11-19
Start date
2021-03-11
Completion date
2024-07-14
Last updated
2025-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Ischemic Stroke

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.

Interventions

OTHERAtrial fibrillation risk electronic health record alert

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

Sponsors

Boston University
CollaboratorOTHER
Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Exclusion criteria

* Patients not meeting above inclusion criteria

Design outcomes

Primary

MeasureTime frameDescription
Incidence of cardiac rhythm monitoring6-monthsIncidence 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.

Secondary

MeasureTime frameDescription
Proportion of patients with ambulatory wearable cardiac rhythm monitoring orders12-monthsProportion of patients with wearable cardiac rhythm monitor ordered at discharge, 6-months, and 12-months. Wearable cardiac rhythm monitoring orders will be ascertained based on electronic health record documentation.
Proportion of patients with cardiac monitor ordered by neurologist1-monthProportion of patients with cardiac monitor ordered by the neurologist at discharge. Cardiac monitor orders by the neurologist will be ascertained based on electronic health record documentation.
Proportion of patients with a new atrial fibrillation diagnosis12-monthsProportion of patients with a new diagnosis of atrial fibrillation at 12-months following discharge for acute ischemic stroke based on electronic health record documentation.
Proportion of patients with implantable loop recorder orders12-monthsProportion of patients with implantable loop recorder ordered at discharge, 6-months, and 12-months. Implantable loop recorder orders will be ascertained based on electronic health record documentation.
Proportion of patients deceased12-monthsProportion of patients who die within 12-months of discharge for acute ischemic stroke. Death will be ascertained based on electroni health record documentation.
Proportion of patients with transesophageal echocardiogram utilization3-monthsProportion of patients with transesophageal echocardiogram (TEE) within 3-months of discharge for acute ischemic stroke. Transesophageal echocardiogram utilization will be ascertained based on electronic health record documentation.
Proportion of patients with oral anticoagulation prescription12-monthsProportion of patients with a new prescription for oral anticoagulation within 12-months of discharge following acute ischemic stroke. Prescriptions for oral anticoagulation will be ascertained based on electronic health record documentation.
Proportion of patients with recurrent stroke12-monthsProportion of patients with recurrent stroke occurring within 12-months of discharge for an initial acute ischemic stroke. Recurrent stroke will be ascertained based on electronic health record documentation.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026