Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06308094
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-03-06
Brief Title:
320-detector Computed Tomography to Assess Myocardial Extracellular Volume Fraction in Patients With Atrial Fibrillation Before AF Ablation
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
320-detector Computed Tomography to Assess Myocardial Extracellular Volume Fraction in Patients With Atrial Fibrillation Before AF Ablation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study explores the relationship between myocardial fibrosis and patient outcomes in Atrial Fibrillation AF specifically after catheter ablation It aims to use Cardiac CT an accessible tool to measure left ventricular extracellular volume ECV as an indicator of fibrosis The study will assess if higher ECV levels correlate with increased risks of AF recurrence hospitalization and poor cardiac function recovery Positive findings could make ECV a key factor in deciding AF treatment strategies
Detailed Description:
Atrial Fibrillation AF is the most common arrhythmia and is associated with significant healthcare-related expenses With the aging population the prevalence of AF is increasing AF frequently co-exists with heart failure HF with reduced HFrEF or preserved HFpEF ejection fraction The relationship between AF and HF is complex and one condition constitutes a risk factor for the other Myocardial interstitial fibrosis is a hallmark of myocardial remodeling occurring as a consequence of risk factor exposure leading to both AF and heart failure However the role of interstitial fibrosis in the prognosis of patients with atrial fibrillation with and without heart failure remains unknown
AF has a significant impact on patients well-being and quality of life In addition to coping with uncomfortable symptoms individuals with this condition face an increased risk of future adverse events like frailty stroke dementia and all-cause mortality To address these concerns many patients opt for procedures such as AF ablation hoping for a cure While the results of this procedure show promise a small percentage of patients who undergo AF ablation may experience a recurrence of the arrhythmia or find that the participants hearts systolic function does not fully recover The investigators aim is to investigate whether there is a connection between myocardial fibrosis and poor outcomes following AF ablation
Cardiac MRI CMR has been the gold standard methodology of quantification of interstitial fibrosis Diffuse interstitial fibrosis can be quantified by extracellular volume ECV imaging CMR-based left ventricular ECV has been associated with adverse outcomes in multiple cardiovascular disease states However the availability of CMR is confined only to tertiary centers with expertise Cardiac CT is an alternative way to detect and quantify interstitial fibrosis by quantification of ECV CT-derived ECV has been shown in multiple studies to have an excellent correlation with CMR-derived ECV Cardiac CT is widely available and has a higher spatial resolution Since as part of the standard pre-ablation routine patients will undergo a cardiac CT scan to accurately map the anatomy of the participants heart investigators ought to measure ECV parameters during this visit
AF has a significant impact on patients well-being and quality of life In addition to coping with uncomfortable symptoms individuals with this condition face an increased risk of future adverse events like frailty stroke dementia and all-cause mortality To address these concerns many patients opt for procedures such as AF ablation hoping for a cure While the results of this procedure show promise a small percentage of patients who undergo AF ablation may experience a recurrence of the arrhythmia or find that the participants hearts systolic function does not fully recover The investigators aim is to investigate whether there is a connection between myocardial fibrosis and poor outcomes following AF ablation
Cardiac MRI CMR has been the gold standard methodology of quantification of interstitial fibrosis Diffuse interstitial fibrosis can be quantified by extracellular volume ECV imaging CMR-based left ventricular ECV has been associated with adverse outcomes in multiple cardiovascular disease states However the availability of CMR is confined only to tertiary centers with expertise Cardiac CT is an alternative way to detect and quantify interstitial fibrosis by quantification of ECV CT-derived ECV has been shown in multiple studies to have an excellent correlation with CMR-derived ECV Cardiac CT is widely available and has a higher spatial resolution Since as part of the standard pre-ablation routine patients will undergo a cardiac CT scan to accurately map the anatomy of the participants heart investigators ought to measure ECV parameters during this visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None