B2AD-Risk AFDAS Evolution of Burden of AF

NCT06589700 | Recruiting

• 1 other identifier: 14963
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke; Atrial Fibrillation

Keywords

Implantable Loop Recorder; stroke; Atrial fibrillation

Outcome Measures

Primary Outcomes (2)

• 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\>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

  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 Outcomes (4)

• Progression of biomarkers

  12-months

• Progression in the number of diagnosed risk factors

  12-months

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

  12-months

• Left atrial size

  12-months

Study Arms (1)

Participants with AF Detected After Stroke

EXPERIMENTAL

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

Interventions

Implantable Loop Recorder DEVICE

Patients will be implanted with a loop recorder.

Participants with AF Detected After Stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Luciano A. Sposato: lead

Study Sites (1)

Heart and Brain Lab, Western University

London, Ontario, N6A 5A5, Canada

RECRUITING

Related Publications (8)

• 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.

  PMID: 25908460 BACKGROUND

• 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.

  PMID: 30958508 BACKGROUND

• 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.

  PMID: 30753246 BACKGROUND

• 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.

  PMID: 33982599 BACKGROUND

• 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.

  PMID: 25459239 BACKGROUND

• 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.

  PMID: 28253498 BACKGROUND

• 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.

  PMID: 26764429 BACKGROUND

• 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.

  PMID: 11588306 BACKGROUND

MeSH Terms

Conditions

Stroke; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Luciano A Sposato, MD

  Western University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana Ayan, Pharm MSc

CONTACT

519-685-8500; diana.ayan@lhsc.on.ca

Jennifer Moussa

CONTACT

519-685-8500; jennifer.moussa@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Neurologist, MD, MBA, FRCPC

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: October 16, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: May 7, 2026

Record last verified: 2025-10

Locations

CA (1)