B2AD-Risk AFDAS Evolution of Burden of AF
- Conditions
- StrokeAtrial Fibrillation
- Interventions
- Device: Implantable Loop Recorder
- Registration Number
- NCT06589700
- Lead Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- 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.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 24
- 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)
- Patients not willing to consent
- Permanent or persistent AF
- Allergy to iodinated contrast agents
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Known Paroxysmal AF Implantable Loop Recorder Paroxysmal AF known before stroke onset (KAF). ECG-AFDAS Implantable Loop Recorder Paroxysmal AF found on an admission or Emergency Department ECG (ECG-AFDAS) PCM-AFDAS Implantable Loop Recorder Paroxysmal AF found on 14-day Holter monitoring (PCM-AFDAS)
- Primary Outcome Measures
Name Time Method Progression of AF burden 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.
Total AF burden 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.
- Secondary Outcome Measures
Name Time Method Progression of biomarkers 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
Progression in the number of diagnosed risk factors 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.
Slow left atrial appendage flow and/or thrombus on follow-up CT Heart 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.
Left atrial size 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.
Trial Locations
- Locations (1)
Heart & Brain Lab, Western University
🇨🇦London, Ontario, Canada