Atrial FibrillationPreMISe-AFNCT04637087
Precision Medicine in Ischemic Stroke and Atrial Fibrillation
A study testing Atrial fibrillation risk electronic health record alert in people with Atrial Fibrillation and Ischemic Stroke, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Ischemic Stroke
- What is being tested?
- Atrial fibrillation risk electronic health record alert
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 805 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2021to 14 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients not meeting above inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
- Conditions
- Atrial Fibrillation, Ischemic Stroke
- Being tested
- Atrial fibrillation risk electronic health record alert
- Medical subject headings
- Atrial Fibrillation, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atrial fibrillation risk electronic health record alertOther
Electronic health record best practice alert which displays patient's 5-year risk of developing atrial fibrillation
| Study group | Role | What they receive |
|---|---|---|
| Atrial Fibrillation Risk Estimation Tool | Experimental | 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. Receives: Other: Atrial fibrillation risk electronic health record alert |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6-months
Secondary outcomes (8)
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.
Measured: 12-months
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.
Measured: 12-months
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.
Measured: 1-month
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.
Measured: 12-months
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.
Measured: 12-months
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.
Measured: 12-months
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.
Measured: 3-months
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.
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start11 Mar 2021
- Primary completion10 Mar 2022
- Study completion14 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 805 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Boston University
- Responsible party
- Principal investigator, Christopher D. Anderson, MD, MMSc, Brigham and Women's Hospital
- Investigators
- Christopher D Anderson, MD, MMSc, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04637087
- Sponsor's protocol ID
- 2020P001382
- Acronym
- PreMISe-AF
- Status last verified
- May 2024
- First submitted
- 13 Nov 2020
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ashburner JM, Tack RWP, Khurshid S, Turner AC, Atlas SJ, Singer DE, Ellinor PT, Benjamin EJ, Trinquart L, Lubitz SA, Anderson CD. Impact of a clinical atrial fibrillation risk estimation tool on cardiac rhythm monitor utilization following acute ischemic stroke: A prepost clinical trial. Am Heart J. 2025 Jun;284:57-66. doi: 10.1016/j.ahj.2025.02.010. Epub 2025 Feb 18.
PubMed 39978665
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Medicine in Ischemic Stroke and Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04637087
- Acronym / sponsor ID
- PreMISe-AF / 2020P001382
- Conditions
- Atrial Fibrillation, Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 805 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Boston University
- Study start
- 11 Mar 2021 (actual)
- Primary completion
- 10 Mar 2022 (actual)
- Study completion
- 14 Jul 2024 (actual)
- First posted
- 19 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atrial Fibrillation Risk Estimation Tool | Experimental | Other: Atrial fibrillation risk electronic health record alertFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patients not meeting above inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atrial fibrillation risk electronic health record alertElectronic health record best practice alert which displays patient's 5-year risk of developing atrial fibrillation | Other | Atrial Fibrillation Risk Estimation Tool |
Primary outcome
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.
8 secondary outcomes
Proportion of patients with implantable loop recorder orders
Time frame: 12-months
Proportion of patients with ambulatory wearable cardiac rhythm monitoring orders
Time frame: 12-months
Proportion of patients with cardiac monitor ordered by neurologist
Time frame: 1-month
Proportion of patients with a new atrial fibrillation diagnosis
Time frame: 12-months
Proportion of patients with recurrent stroke
Time frame: 12-months
Proportion of patients deceased
Time frame: 12-months
Proportion of patients with transesophageal echocardiogram utilization
Time frame: 3-months
Proportion of patients with oral anticoagulation prescription
Time frame: 12-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Derived from this study: PubMed 39978665Ashburner JM, Tack RWP, Khurshid S, Turner AC, Atlas SJ, Singer DE, Ellinor PT, Benjamin EJ, Trinquart L, Lubitz SA, Anderson CD. Impact of a clinical atrial fibrillation risk estimation tool on cardiac rhythm monitor utilization following acute ischemic stroke: A prepost clinical trial. Am Heart J. 2025 Jun;284:57-66. doi: 10.1016/j.ahj.2025.02.010. Epub 2025 Feb 18.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher D Anderson, MD, MMSc principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atrial fibrillation risk electronic health record alert in people with Atrial Fibrillation and Ischemic Stroke, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of cardiac rhythm monitoring (time frame: 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04637087, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.