B2AD-Risk AFDAS Evolution of Burden of AF (B2AD-Risk AF)

May 3, 2026 updated by: Luciano A. Sposato

Evolution of Burden of AF Biomarkers, Left Atrial Characteristics, Demographics,and Risk Factors in AF Detected After Stroke

Each year, 7.8 million people worldwide experience an ischemic stroke, often caused by atrial fibrillation (AF). AF is a major contributor to severe, disabling, and deadly strokes. About 20% to 30% of ischemic stroke patients have AF before their stroke. Of the remaining 70% to 80% without known arrhythmias, up to 24% are newly diagnosed with AF after intensive cardiac monitoring, totaling 1.3 to 1.5 million new AF cases detected after stroke globally each year. Oral anticoagulants (OACs) can reduce stroke risk related to AF by 64% and lead to milder strokes with lower disability and mortality. Neurologists use cardiac monitoring to detect AF in stroke patients.

This study focuses on patients who have had an ischemic stroke and are newly diagnosed with AF. The goal is to understand how AF progresses over time. The investigators will track changes in AF severity and frequency, monitor biomarkers related to heart health, assess the size and function of the left atrium, and observe new risk factors like hypertension. Patients will be grouped based on their AF diagnosis method: ECG, a portable device recording heart activity for less than 7 days, or one recording for 7 to 30 days.

The investigators hypothesize that AF burden will increase, new risk factors will emerge, biomarkers will rise, and the left atrium will worsen over time. Participants will be followed for up to 24 months with regular assessments. The study aims to provide insights into AF progression in stroke patients, potentially improving treatments and prevention strategies.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Globally, 7.8 million individuals experience an ischemic stroke each year.1, 2 Atrial fibrillation (AF) is one of the most frequent causes of ischemic stroke, resulting in the most severe, disabling, and lethal events.1, 2 Around 20% to 30% of ischemic stroke patients have AF before stroke occurrence.13, 14 Among the remaining 70% to 80% without known arrhythmias, up to 24% can be newly diagnosed with AF after intensive cardiac monitoring (Figure 1), yielding a rough estimate of 1.3 to 1.5 million new cases of AF detected after stroke (AFDAS) globally each year.15-17 Most AFs are diagnosed before a stroke ever occurs. Among persons with additional stroke risk factor, OACs reduce AF-related stroke risk by 64% compared to no treatment.18 Also, patients who have ischemic strokes despite receiving OACs have milder19 and smaller strokes20, resulting in reduced disability21 and mortality21. Neurologists use cardiac monitoring in patients with ischemic stroke to look for AF.

The main goal of this study is to observe and understand how AF progresses over time in patients with AFDAS. Specifically, the investigators aim to track changes in the severity and frequency of AF episodes, monitor biomarkers (substances in the blood that indicate disease) related to heart health, measure changes in the size and function of the left atrium (a chamber of the heart), and analyze changes in risk factors such as new diagnoses of hypertension (high blood pressure). Patients will be grouped based on how their AF was diagnosed: using an electrocardiogram (ECG-based diagnosis), using a portable device that records heart activity for less than 7 days (<7-day Holter monitor), or using a portable device that records heart activity for 7 to 30 days (7-30-day Holter monitor).

The investigators hypothesize that the burden of AF (severity and frequency of AF episodes) will increase over time, risk factors such as newly diagnosed hypertension will emerge, biomarkers indicating heart stress and damage will increase, and the left atrium will show signs of worsening function and increased size. The underlying idea is that patients with initially low AF burden might have a "young" form of AF that gradually worsens, increasing their risk of stroke. Therefore, the investigators will evaluate the progression of AF burden over time. Throughout the study, the investigators will regularly measure AF burden (frequency and severity of episodes), levels of specific biomarkers (e.g., MR-proANP, 0troponin), blood pressure, weight, and development of risk factors. Participants will be followed up to 24 months.

To gather data, the investigators will use recording of AF burden, echocardiography (imaging to assess heart structure and function), plasma biomarkers (blood tests to measure substances indicating heart health), and cardiac CT scans at the beginning and end of the study to assess heart health. This study aims to provide valuable insights into how AF evolves in stroke patients, potentially leading to better treatments and prevention strategies for reducing stroke risk.

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • 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 Backup

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • Recruiting
        • Heart and Brain Lab, Western University
        • Principal Investigator:
          • Luciano Sposato, MD, MBA
        • Contact:

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients with cortical or subcortical, cryptogenic or non-cryptogenic acute ischemic stroke
  • Any of the following types of AF:
  • Paroxysmal AF known before stroke onset (KAF).
  • Paroxysmal AF found on an admission or Emergency Department ECG (ECG-AFDAS)
  • Paroxysmal AF found on 14-day Holter monitoring (PCM-AFDAS)

Exclusion Criteria:

  • Patients not willing to consent
  • Permanent or persistent AF
  • Allergy to iodinated contrast agents

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants with AF Detected After Stroke
Participants with AF detected after stroke undergo implantation of an insertable cardiac monitor (loop recorder) for continuous cardiac rhythm monitoring to detect and characterize atrial fibrillation burden, biomarkers, and left atrial characteristics over time.
Device: Implantable Loop Recorder
Patients will be implanted with a loop recorder.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression of AF burden
Time Frame: 12-months
Difference in the total duration of AF during the first quartile of available follow-up compared to the last quartile of follow-up. We hypothesize that AF burden will progress at a different pace in different types of AF: KAF>ECG-AF>PCM-AFDAS. As a sensitivity analysis AF burden will be compared at the first and 12 months of follow-up.
12-months
Total AF burden
Time Frame: 12-months
Total AF burden We will compare different measures of AF burden between the 3 types of AF: (1) Total AF burden at 3, 6, and 12 months post-ILR insertion (sum of the duration of all AF episodes, HH:MM:SS), (2) Maximum duration of the longest AF episode, (3) Relative AF burden (total AF burden/net monitoring time), (4) AF Pattern (number of AF episodes and time of occurrence), (5) Time to first AF diagnosis (DD:HH), and (6) Other ECG monitoring findings (premature atrial complexes, interatrial block, etc.). Characterizing these measures will allow us to choose the best AF burden definition for a larger RCT. We hypothesize that the burden of AF will be different across types of AF: KAF>ECG-AF>PCM-AFDAS.
12-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression of biomarkers
Time Frame: 12-months
Difference in the levels of biomarkers between the enrollment visit and the visit at 12 months. We hypothesize that baseline biomarker levels and their increase throughout time will differ across AF groups: KAF>ECG-AF>PCM-AFDAS
12-months
Progression in the number of diagnosed risk factors
Time Frame: 12-months
Difference in the levels of biomarkers between the enrollment visit and the visit at 12 months. We hypothesize that number of risk factors will differ across AF groups: KAF>ECG-AF>PCM-AFDAS.
12-months
Slow left atrial appendage flow and/or thrombus on follow-up CT Heart
Time Frame: 12-months
We will assess the presence of slow left atrial appendage flow and/or thrombus on CT imaging of the heart at 1 month and 12 months. If possible, a CT heart will be done at the last follow-up visit beyond 12 months. We hypothesize that the prevalence at baseline, and incidence at the end of follow-up, of slow left atrial appendage flow and/or thrombus will differ across AF groups: KAF>ECG-AF>PCM-AFDAS.
12-months
Left atrial size
Time Frame: 12-months
We will assess the differences in the size of the left atrium on CT imaging of the heart at 1 month and 12 months. We hypothesize that baseline left atrial size and the progression of LA size will differ across AF groups: KAF>ECG-AF>PCM-AFDAS.
12-months

Collaborators and Investigators

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

Sponsor

Luciano A. Sposato

Investigators

  • Principal Investigator: Luciano A Sposato, MD, Western University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

October 16, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

September 6, 2024

First Submitted That Met QC Criteria

September 6, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 3, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14963

Plan for Individual participant data (IPD)

IPD Plan Description

Upon reasonable request and after the Approval of Western University Ethics Review Board

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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