PreMISe-AF: Precision Medicine in Ischemic Stroke and Atrial Fibrillation

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04637087
Collaborator
Boston University (Other)
1,500
1
1
23.7
63.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Atrial fibrillation risk electronic health record alert
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1500 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Precision Medicine in Ischemic Stroke and Atrial Fibrillation
Actual Study Start Date :
Mar 11, 2021
Actual Primary Completion Date :
Mar 10, 2022
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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

Outcome Measures

Primary Outcome Measures

  1. Incidence of cardiac rhythm monitoring [6-months]

    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

  1. Proportion of patients with implantable loop recorder orders [12-months]

    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.

  2. Proportion of patients with ambulatory wearable cardiac rhythm monitoring orders [12-months]

    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.

  3. Proportion of patients with cardiac monitor ordered by neurologist [1-month]

    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.

  4. Proportion of patients with a new atrial fibrillation diagnosis [12-months]

    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.

  5. Proportion of patients with recurrent stroke [12-months]

    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.

  6. Proportion of patients deceased [12-months]

    Proportion of patients who die within 12-months of discharge for acute ischemic stroke. Death will be ascertained based on electroni health record documentation.

  7. Proportion of patients with transesophageal echocardiogram utilization [3-months]

    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.

  8. Proportion of patients with oral anticoagulation prescription [12-months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Massachusetts General Hospital Boston Massachusetts United States 02114

Sponsors and Collaborators

  • Massachusetts General Hospital
  • Boston University

Investigators

  • Principal Investigator: Christopher D Anderson, MD, MMSc, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Christopher D. Anderson, MD, MMSc, Division Chief, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT04637087
Other Study ID Numbers:
  • 2020P001382
First Posted:
Nov 19, 2020
Last Update Posted:
Aug 18, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 18, 2022