Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06308094 |
| Other study ID # |
IRB00429859 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2024 |
| Est. completion date |
April 1, 2025 |
Study information
| Verified date |
April 2024 |
| Source |
Johns Hopkins University |
| Contact |
Konstantinos Aronis, MD PHD |
| Phone |
2017169226 |
| Email |
karonis1[@]jhmi.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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 participant's
heart's 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 participant's heart,
investigators ought to measure ECV parameters during this visit.
