Impact of Atrial Fibrillation Prediction Model on Prescribing Oral Anti-Coagulation in Patients With Cryptogenic Stroke

November 6, 2026 updated by: Samir Saba

Prediction of Atrial Fibrillation in Patients With Embolic Stroke of Unknown Source

Stroke is a major cause of disability and the second leading cause of death in adults. Some strokes are linked to atrial fibrillation (AF), a type of irregular heartbeat. When AF is found, doctors usually prescribe blood-thinning medicines to help prevent another stroke. If AF is not found, patients are usually treated with antiplatelet medicines, such as aspirin.

However, AF can be difficult to detect. Because of this, doctors may not know which treatment is best.

Our research team has developed computer programs that analyze a normal electrocardiogram (EKG) and predict whether a person may develop AF in the future. These programs have been shown to be highly accurate.

The goal of this study is to see how sharing these prediction results affects treatment decisions made by patients who have had an embolic stroke of undetermined source (ESUS) and their neurologist. An ESUS is a type of stroke where the exact cause cannot be identified.

Participants in the study will have their normal EKG analyzed using the prediction program. Researchers will then evaluate whether providing these results to the neurologist influences decisions about the patient's care.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients presenting to outpatient or inpatient stroke services or to the inpatient cardiac procedure unit for implantation of implantable cardiac monitor at the hospitals of UPMC and who have suffered an ischemic stroke without overt clinical etiology will be considered for participation in this clinical trial. The research coordinator for the trial will screen the inpatient services and outpatient clinics and will verify that any prospective subject meets all the inclusion and none of the exclusion criteria. Once this information is ascertained, the investigator, research coordinator, or both will approach the patient to explain the rationale of the study and its requirements after a clinician known to the participant has obtained their permission to be approached. After signing written informed consent, patients will be enrolled into the study whereby the normal sinus rhythm EKG will be analyzed using the novel machine learning method to assess the patient's risk for developing AF in the following year. Participants will undergo standard of care monitoring on an outpatient basis which includes initially a wearable monitor and then an implantable monitor if the wearable monitor does not reveal AF. If any monitoring reveals AF, then the patients will be on anticoagulation, as indicated in any patient with stroke and AF. This information will be shared with the treating neurologist.

Once a patient is enrolled, their baseline normal EKG will be analyzed using the machine learning algorithm and their risk category for developing AF will be determined. The results which are classified into low, intermediate, and high risk will be presented to the stroke team. The stroke specialists will then share these risk prediction data with their patient for shared decision-making regarding anticoagulation strategy -- oral anticoagulation (OAC) vs. Aspirin. When the information from the novel learning method is shared with the treating neurologist or stroke specialist, the research team will remind them that this is a research tool and has not been fully validated.

The machine learning algorithm, referred to for research purposes as the UPMC AF Prediction Model, was developed under STUDY20030038. The algorithm performance was tested and validated on more than 26,000 patients, 23% of whom developed AF over the course of one year after their original normal EKG. The algorithm performance shows an area under the Receiver Operating Characteristic curve of 0.800 with an F1 score of 0.42. Accordingly, the risk groups in the study were defined as follows, after consultation with stroke specialists:

A. Low risk group, based on a negative predictive value of 97.5% (i.e., only 2.5% of patients classified as low risk will develop AF over 1-year of follow-up) B. High risk group, based on a positive predictive value of 30% (i.e., 30% of patients classified as high risk will develop AF over 1-year of follow-up) C. Intermediate risk group, which will include patients who do not belong in either of the two previous risk groups

Patients will be followed up for 90 days for clinical events. Follow-up at 30 and 90 days will consist of phone calls and review of electronic health records. The rate of use of OAC will be assessed at 30 and 90 days in each AF risk category.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Samir Saba, MD
  • Phone Number: 412-647-2762
  • Email: sabas@upmc.edu

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient presenting with embolic stroke of unclear source.
  • Age at least 18 years.
  • Patients will be enrolled within 30 days of stroke.

Exclusion Criteria:

  • Prior history of AF
  • Stroke can be attributed to cancer, hypercoagulable state, or large artery non-stenotic plaque
  • Contraindication to OAC or antiplatelet therapy, including the presence of hemorrhagic stroke
  • Patient is already on OAC
  • Patient had prior procedure or surgery to exclude or excise the left atrial appendage
  • Patient unable or unwilling to provide written informed consent to participate in research

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: UPMC AF Prediction Model

Patients presenting to outpatient or inpatient stroke services or to the inpatient cardiac procedure unit for implantation of implantable cardiac monitor at the hospitals of UPMC and who have suffered an ischemic stroke without overt clinical etiology will be considered for participation in this trial. Once a patient is enrolled, their baseline normal EKG will be analyzed using the machine learning algorithm and their risk category for developing AF will be determined. The results, which are classified into low, intermediate, and high risk, will be presented to the stroke team. The stroke specialists will then share these risk prediction data with their patient for shared decision-making regarding anticoagulation strategy (OAC vs. Aspirin). Patients will be followed up for 90 days for clinical events. Follow-up at 30 and 90 days will consist of phone calls and review of electronic health records. The rate of use of OAC will be assessed at 30 and 90 days in each AF risk category.
Device: UPMC AF Prediction Model

Enrolled patients' baseline normal EKG will be analyzed using the UPMC AF Prediction Model and their risk category for developing AF will be determined. The results, which are classified into low, intermediate, and high risk, will be presented to the stroke team. The stroke specialists will then share these risk prediction data with their patient for shared decision-making regarding anticoagulation strategy (OAC vs. Aspirin). Patients will be followed up for 90 days for clinical events. Follow-up at 30 and 90 days will consist of phone calls and review of electronic health records. The rate of use of OAC will be assessed at 30 and 90 days in each AF risk category.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rates of Prescribing OAC versus Antiplatelet Agent
Time Frame: From enrollment until assessment at 90 days

The primary endpoint of this trial is the rates of prescribing OAC versus antiplatelet agent after 30 days and after 90 days of patient enrollment, and before any diagnosis of AF is made. In the unlikely event that a patient is diagnosed with AF in the first 30 days after enrollment, their OAC status before the AF diagnosis is made will be recorded and used as the primary endpoint. Patients will be followed up for a total of 90 days for clinical events. All follow-up visits will consist of phone calls and review of electronic health records. The rate of use of OAC will be assessed at 90 days in each AF risk category.
From enrollment until assessment at 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Samir Saba

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Samir Saba, MD, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY25100011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings