Recruiting

Atrial Fibrillation

Sponsor:

Luciano A. Sposato

Code:

NCT06589700

Conditions

Stroke

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Implantable Loop Recorder

Study Details

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

Study ID

NCT06589700

Start date

Oct 16, 2025

Status verified date

Oct, 2025

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

24 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

Implantable Loop Recorder

Patients will be implanted with a loop recorder.

Primary outcome measure

  • Progression of AF burden [ Time Frame: 12-months ]
  • Total AF burden [ Time Frame: 12-months ]

Central Contacts and Locations

Central contacts

Locations

Heart and Brain Lab, Western University

Recruiting

London, Ontario, Canada, N6A 5A5

Contacts

Principal Investigator:

Luciano Sposato, MD, MBA

More Information

Sponsor

Luciano A. Sposato

Last update posted

May 7, 2026

Last verified

Oct, 2025

Keywords

  • Implantable Loop Recorder
  • stroke
  • Atrial fibrillation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Luciano A. Sposato on 2026-05-07.