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Precision Medicine in Ischemic Stroke and Atrial Fibrillation (PreMISe-AF)

Primary Purpose

Atrial Fibrillation, Ischemic Stroke

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Atrial fibrillation risk electronic health record alert
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Atrial Fibrillation Risk Estimation Tool

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Proportion of patients with implantable loop recorder orders
Proportion 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 with ambulatory wearable cardiac rhythm monitoring orders
Proportion 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 neurologist
Proportion 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 diagnosis
Proportion 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 recurrent stroke
Proportion 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.
Proportion of patients deceased
Proportion 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 utilization
Proportion 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 prescription
Proportion 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.

Full Information

First Posted
November 13, 2020
Last Updated
October 6, 2023
Sponsor
Massachusetts General Hospital
Collaborators
Boston University
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1. Study Identification

Unique Protocol Identification Number
NCT04637087
Brief Title
Precision Medicine in Ischemic Stroke and Atrial Fibrillation
Acronym
PreMISe-AF
Official Title
Precision Medicine in Ischemic Stroke and Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 11, 2021 (Actual)
Primary Completion Date
March 10, 2022 (Actual)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Boston University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Ischemic Stroke

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Atrial Fibrillation Risk Estimation Tool
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Atrial fibrillation risk electronic health record alert
Intervention Description
Electronic health record best practice alert which displays patient's 5-year risk of developing atrial fibrillation
Primary Outcome Measure Information:
Title
Incidence of cardiac rhythm monitoring
Description
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.
Time Frame
6-months
Secondary Outcome Measure Information:
Title
Proportion of patients with implantable loop recorder orders
Description
Proportion 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.
Time Frame
12-months
Title
Proportion of patients with ambulatory wearable cardiac rhythm monitoring orders
Description
Proportion 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.
Time Frame
12-months
Title
Proportion of patients with cardiac monitor ordered by neurologist
Description
Proportion 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.
Time Frame
1-month
Title
Proportion of patients with a new atrial fibrillation diagnosis
Description
Proportion of patients with a new diagnosis of atrial fibrillation at 12-months following discharge for acute ischemic stroke based on electronic health record documentation.
Time Frame
12-months
Title
Proportion of patients with recurrent stroke
Description
Proportion 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.
Time Frame
12-months
Title
Proportion of patients deceased
Description
Proportion of patients who die within 12-months of discharge for acute ischemic stroke. Death will be ascertained based on electroni health record documentation.
Time Frame
12-months
Title
Proportion of patients with transesophageal echocardiogram utilization
Description
Proportion 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.
Time Frame
3-months
Title
Proportion of patients with oral anticoagulation prescription
Description
Proportion 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.
Time Frame
12-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher D Anderson, MD, MMSc
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Precision Medicine in Ischemic Stroke and Atrial Fibrillation

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