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B2AD-Risk AFDAS Evolution of Burden of AF

ConditionsStrokeAtrial Fibrillation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLuciano A. Sposato

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients with cortical or subcortical, cryptogenic or non-cryptogenic acute ischemic stroke

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)

Disqualifiers

Patients not willing to consent

Permanent or persistent AF

Allergy to iodinated contrast agents

Trial design

Design model

Single group

Treatments tested in this trial

  • Implantable Loop Recorder

    Device

    Patients will be implanted with a loop recorder.

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: Participants with AF Detected After StrokeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Time frame
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\>ECG-AF\>PCM-AFDAS.

Time frame
12-months

Secondary outcomes

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\>ECG-AF\>PCM-AFDAS

Time frame
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\>ECG-AF\>PCM-AFDAS.

Time frame
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\>ECG-AF\>PCM-AFDAS.

Time frame
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\>ECG-AF\>PCM-AFDAS.

Time frame
12-months

Other outcomes

Sponsors and contacts

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Luciano A. Sposato

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Sponsor institution

Source ClinicalTrials.gov
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