AzTrials
AzTrials

StrokeB2AD-Risk AFNCT06589700

B2AD-Risk AFDAS Evolution of Burden of AF

A study testing Implantable Loop Recorder in people with Stroke and Atrial Fibrillation, run by Luciano A. Sposato at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Atrial Fibrillation
What is being tested?
Implantable Loop Recorder
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteCanada
Study dates
16 Oct 2025to Oct 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • 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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Canada1 site, 1 recruiting
  • Heart and Brain Lab, Western University

    London, Ontario, N6A 5A5

    Diana Ayan, Pharm MSc, 519-685-8500 ext. 35826, diana.ayan@lhsc.on.ca

    Luciano Sposato, MD, MBA

    Recruiting

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
Implantable Loop Recorder
Keywords
Implantable Loop Recorder, stroke, Atrial fibrillation
Medical subject headings
Stroke, Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Implantable Loop RecorderDevice

    Patients will be implanted with a loop recorder.

Study groups in NCT06589700
Study groupRoleWhat they receive
Participants with AF Detected After StrokeExperimentalParticipants 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.
Receives: Device: Implantable Loop Recorder

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression of AF burden

    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\&gt;ECG-AF\&gt;PCM-AFDAS. As a sensitivity analysis AF burden will be compared at the first and 12 months of follow-up.

    Measured: 12-months

  2. Total AF burden

    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\&gt;ECG-AF\&gt;PCM-AFDAS.

    Measured: 12-months

Secondary outcomes (4)
  1. Progression of biomarkers

    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\&gt;ECG-AF\&gt;PCM-AFDAS

    Measured: 12-months

  2. Progression in the number of diagnosed risk factors

    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\&gt;ECG-AF\&gt;PCM-AFDAS.

    Measured: 12-months

  3. Slow left atrial appendage flow and/or thrombus on follow-up CT Heart

    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\&gt;ECG-AF\&gt;PCM-AFDAS.

    Measured: 12-months

  4. Left atrial size

    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\&gt;ECG-AF\&gt;PCM-AFDAS.

    Measured: 12-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start16 Oct 2025
  3. Primary completionOct 2027 (estimated)
  4. Study completionOct 2027 (estimated)

Resources

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
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06589700
Sponsor's protocol ID
14963
Acronym
B2AD-Risk AF
Status last verified
Oct 2025
First submitted
6 Sep 2024
Last updated
7 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Yaghi S, Moon YP, Mora-McLaughlin C, Willey JZ, Cheung K, Di Tullio MR, Homma S, Kamel H, Sacco RL, Elkind MS. Left atrial enlargement and stroke recurrence: the Northern Manhattan Stroke Study. Stroke. 2015 Jun;46(6):1488-93. doi: 10.1161/STROKEAHA.115.008711. Epub 2015 Apr 23.

    PubMed 25908460
  • Healey JS, Gladstone DJ, Swaminathan B, Eckstein J, Mundl H, Epstein AE, Haeusler KG, Mikulik R, Kasner SE, Toni D, Arauz A, Ntaios G, Hankey GJ, Perera K, Pagola J, Shuaib A, Lutsep H, Yang X, Uchiyama S, Endres M, Coutts SB, Karlinski M, Czlonkowska A, Molina CA, Santo G, Berkowitz SD, Hart RG, Connolly SJ. Recurrent Stroke With Rivaroxaban Compared With Aspirin According to Predictors of Atrial Fibrillation: Secondary Analysis of the NAVIGATE ESUS Randomized Clinical Trial. JAMA Neurol. 2019 Jul 1;76(7):764-773. doi: 10.1001/jamaneurol.2019.0617.

    PubMed 30958508
  • Vafaie M, Giannitsis E, Mueller-Hennessen M, Biener M, Makarenko E, Yueksel B, Katus HA, Stoyanov KM. High-sensitivity cardiac troponin T as an independent predictor of stroke in patients admitted to an emergency department with atrial fibrillation. PLoS One. 2019 Feb 12;14(2):e0212278. doi: 10.1371/journal.pone.0212278. eCollection 2019.

    PubMed 30753246
  • Scheitz JF, Lim J, Broersen LHA, Ganeshan R, Huo S, Sperber PS, Piper SK, Heuschmann PU, Audebert HJ, Nolte CH, Siegerink B, Endres M, Liman TG. High-Sensitivity Cardiac Troponin T and Recurrent Vascular Events After First Ischemic Stroke. J Am Heart Assoc. 2021 May 18;10(10):e018326. doi: 10.1161/JAHA.120.018326. Epub 2021 May 13.

    PubMed 33982599
  • Shibazaki K, Kimura K, Aoki J, Sakai K, Saji N, Uemura J. Brain natriuretic peptide level on admission predicts recurrent stroke after discharge in stroke survivors with atrial fibrillation. Clin Neurol Neurosurg. 2014 Dec;127:25-9. doi: 10.1016/j.clineuro.2014.09.028. Epub 2014 Oct 5.

    PubMed 25459239
  • Maruyama K, Uchiyama S, Shiga T, Iijima M, Ishizuka K, Hoshino T, Kitagawa K. Brain Natriuretic Peptide Is a Powerful Predictor of Outcome in Stroke Patients with Atrial Fibrillation . Cerebrovasc Dis Extra. 2017;7(1):35-43. doi: 10.1159/000457808. Epub 2017 Mar 2.

    PubMed 28253498
  • Kaatz S, Ahmad D, Spyropoulos AC, Schulman S; Subcommittee on Control of Anticoagulation. Definition of clinically relevant non-major bleeding in studies of anticoagulants in atrial fibrillation and venous thromboembolic disease in non-surgical patients: communication from the SSC of the ISTH. J Thromb Haemost. 2015 Nov;13(11):2119-26. doi: 10.1111/jth.13140. No abstract available.

    PubMed 26764429
  • Jones WJ, Williams LS, Meschia JF. Validating the Questionnaire for Verifying Stroke-Free Status (QVSFS) by neurological history and examination. Stroke. 2001 Oct;32(10):2232-6. doi: 10.1161/hs1001.096191.

    PubMed 11588306

Questions about this trial

What is this clinical trial studying?

A study testing Implantable Loop Recorder in people with Stroke and Atrial Fibrillation, run by Luciano A. Sposato at 1 site in Canada.

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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 7 May 2026. 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 Canada. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Diana Ayan, Pharm MSc (519-685-8500 ext. 35826, diana.ayan@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression of AF burden (time frame: 12-months). The study lists 2 primary outcomes in all. 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 NCT06589700, which also lists 8 linked publications.

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 2026; AzTrials last refreshed its copy on 6 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in