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Clinical Trials/NCT04637087
NCT04637087CompletedNot Applicable

Precision Medicine in Ischemic Stroke and Atrial Fibrillation

Massachusetts General Hospital2 sites in 1 country805 target enrollmentStarted: March 11, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
805
Locations
2
Primary Endpoint
Incidence of cardiac rhythm monitoring

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

Incidence of cardiac rhythm monitoring

Time Frame: 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 Outcomes

  • Proportion of patients with a new atrial fibrillation diagnosis(12-months)
  • Proportion of patients with oral anticoagulation prescription(12-months)
  • Proportion of patients with implantable loop recorder orders(12-months)
  • Proportion of patients with cardiac monitor ordered by neurologist(1-month)
  • Proportion of patients with recurrent stroke(12-months)
  • Proportion of patients with transesophageal echocardiogram utilization(3-months)
  • Proportion of patients with ambulatory wearable cardiac rhythm monitoring orders(12-months)
  • Proportion of patients deceased(12-months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Christopher D. Anderson, MD, MMSc

Division Chief

Brigham and Women's Hospital

Study Sites (2)

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