Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06589700
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
B2AD-Risk AFDAS Evolution of Burden of AF
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evolution of Burden of AF Biomarkers Left Atrial Characteristics Demographicsand Risk Factors in AF Detected After Stroke
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
B2AD-Risk AF
Brief Summary:
Each year 78 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 13 to 15 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 We 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
We 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
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 We 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
We 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 78 million individuals experience an ischemic stroke each year1 2 Atrial fibrillation AF is one of the most frequent causes of ischemic stroke resulting in the most severe disabling and lethal events1 2 Around 20 to 30 of ischemic stroke patients have AF before stroke occurrence13 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 13 to 15 million new cases of AF detected after stroke AFDAS globally each year15-17 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 treatment18 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 we 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
We 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 we will evaluate the progression of AF burden over time Throughout the study we will regularly measure AF burden frequency and severity of episodes levels of specific biomarkers eg MR-proANP 0troponin blood pressure weight and development of risk factors Participants will be followed up to 24 months
To gather data we 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
The main goal of this study is to observe and understand how AF progresses over time in patients with AFDAS Specifically we 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
We 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 we will evaluate the progression of AF burden over time Throughout the study we will regularly measure AF burden frequency and severity of episodes levels of specific biomarkers eg MR-proANP 0troponin blood pressure weight and development of risk factors Participants will be followed up to 24 months
To gather data we 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None