An observational study in Atrial Fibrillation and Atrial Inflammation, sponsored by Cardio Med Medical Center. Completed at 1 site in Romania. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-02.
Sponsored by Cardio Med Medical Center · Observational
FIBRO-RISK study aims to investigate the impact of inflammatory-mediated myocardial fibrosis on the risk of recurrence after successful ablation of atrial fibrillation. The level of systemic inflammation in the pre-ablation and immediate post-ablation period will be assessed on the basis of serum levels of inflammatory biomarkers (hs-CRP, matrix metalloproteases, interleukin-6), while the level of cardiac fibrosis will be determined based on MRI imaging associated with complex post-processing techniques for mapping myocardial fibrosis at the level of left atrium and left ventricle. At the same time, the amount of epicardial fat will serve as an indirect marker of localized inflammation and will be determined at different levels in the heart (surrounding left atrium, right atrium or the entire heart), while ventricular function will be assessed on the basis of serum levels of NT pro-BNP prior to the procedure. All these parameters will be investigated in patients with successful ablation of AF, who will be divided into 2 groups: group 1 - patients who develop AF recurrence at 1-year, and group 2 - patients with no recurrence of AF at 1-year. In all patients, the following biomarkers will be determined: serum levels of inflammatory biomarkers and NT-proBNP at 24 hours and 1 year post-procedure, the amount of myocardial fibrosis at the level of left atrium and left ventricle at baseline +/- 7 days and the amount of epicardial fat surrounding left atrium, right atrium and the entire heart at baseline +/- 7 days.
The primary endpoint of the study will be represented by the rate of AF recurrence at 1-year post ablation, documented by either ECG or Holter monitoring.
The secondary endpoints of the study will be:
The prevalence of atrial fibrillation (AF) is on the rise, being the most frequent sustained supraventricular arrhythmia and a health issue by its increased morbidity and mortality. In most of the cases, myocardial tissue located at the level of the pulmonary veins represents the trigger for atrial fibrillation. The pathophysiology of AF is still incompletely understood, several studies suggesting that profibrotic and inflammatory processes have a crucial role in the development of AF. So far the success rate of AF ablation is not very high, reaching 70% in patients with paroxysmal AF and 50% in cases with persistent AF. Several risk factors for the occurrence and recurrence of AF have been described in the literature, including left atrial enlargement, left ventricular dysfunction, epicardial fat volume, and myocardial fibrosis caused by local atrial inflammation. What remains to be investigated is the relationship between these risk factors and the recurrence of AF after radiofrequency catheter ablation using advanced 3D mapping system.
This is a clinical prospective, descriptive, single-center study which will be carried out in the Center of Advanced Research in Multimodal Cardiac Imaging Cardiomed Tirgu Mures, Romania. The duration of the study is 2 years which include the initial screening and the follow-up period for the recurrence of AF.
The study will include 100 subjects suitable for catheter ablation. Imaging biomarkers and laboratory analyses such as high sensitive C Reactive Protein (hsCRP), matrix metalloproteases (MMP), interleukin-6 (IL6) and N-Terminal Pro-B-Type Natriuretic Peptide (NT pro-BNP) will be determined in the first 24 hours after the procedure. The anatomy of pulmonary veins, atrial fibrosis, atrial volumes and the amount of epicardial fat will be evaluated and quantified with late gadolinium-enhancement cardiac magnetic resonance (LGE-CMR). All these parameters will be investigated in patients with successful ablation of AF, who will be divided into 2 groups: group 1 - patients who develop AF recurrence at 1-year, and group 2 - patients with no recurrence of AF at 1-year. In all patients, the following biomarkers will be determined: serum levels of inflammatory biomarkers and NT-proBNP at 24 hours and 1 year post-procedure, the amount of myocardial fibrosis at the level of left atrium and left ventricle at baseline +/- 7 days and the amount of epicardial fat surrounding left atrium, right atrium and the entire heart at baseline +/- 7 days.
The study will be conducted over a period of 2 years, in which patients will be examined at baseline, and will be followed-up for recurrence of AF.
All patients will sign an informed written consent and will be checked for the exclusion criteria prior to enrolment.
Study objectives:
Primary: To investigate the correlation between imaging markers provided by cardiac magnetic resonance (including the degree of left atrial and ventricular fibrosis, left and right atrial volume, epicardial fat tissue volume), inflammatory biomarkers, and the risk of AF recurrence post ablation.
Secondary: To investigate the correlation between structural remodeling of the left and right atrium, epicardial fat tissue volume and serum inflammatory biomarkers in patients with AF.
Study Timeline:
Study procedures:
Data collection: All the information will be collected in a database that consists of patient's background, medical history, medication, imaging features provided by cardiac ultrasound, Cardiac magnetic resonance and CMR imaging post-processing.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 100 is below the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Cardio Med Medical Center is the lead sponsor of 11 studies on the registry; none are open to participants now.
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Study population includes patients from a single center with paroxysmal and persistent atrial fibrillation, meeting inclusion and exclusion criteria and undergoing pulmonary vein isolation radiofrequency catheter ablation.
Exclusion Criteria:
Study subjects with atrial fibrillation recurrence after ablation: Blood sampling (assessment of complete blood count, biochemistry, inflammatory biomarkers), 2D transthoracic echocardiography, Late Gadolinium-Enhancement Cardiac Magnetic Resonance, and complex left and right atrium analysis, Pulmonary vein isolation radiofrequency ablation
Diagnostic Test: Cardiac imaging tests · Diagnostic Test: Venous blood samle collection
Study subjects without atrial fibrillation recurrence after ablation: Blood sampling (assessment of complete blood count, biochemistry, inflammatory biomarkers), 2D transthoracic echocardiography, Late Gadolinium-Enhancement Cardiac Magnetic Resonance, and complex left and right atrium analysis, Pulmonary vein isolation radiofrequency ablation
Diagnostic Test: Cardiac imaging tests · Diagnostic Test: Venous blood samle collection
2D transthoracic echocardiography; Late gadolinium-enhancement cardiac magnetic resonance with the evaluation of pulmonary veins anatomy, atrial fibrosis, atrial volumes and the amount of epicardial fat will
Venous blood sample collection 1 day prior to the ablation procedure: Serum levels of high sensitive C Reactive Protein, Matrix metalloproteases, Interleukin-6, and N-Terminal Pro-B-Type Natriuretic Peptide.
The rate of AF recurrence after pulmonary vein isolation
The primary outcome measure will be represented by the rate of AF recurrence at 1 year post ablation, documented by either ECG or Holter monitoring.
Time frame: 12 months
Rate of re-hospitalization
The secondary endpoints of the study will be: rate of re-hospitalization, rate of survival without relapse, rate of major adverse cardiovascular events (MACE rate, including cardiovascular death or stroke)
Time frame: 12 months
Rate of survival without relapse
The secondary endpoints of the study will be: rate of re-hospitalization, rate of survival without relapse, rate of major adverse cardiovascular events (MACE rate, including cardiovascular death or stroke)
Time frame: 12 months
Rate of major adverse cardiovascular events (MACE rate, including cardiovascular death or stroke)
The secondary endpoints of the study will be: rate of re-hospitalization, rate of survival without relapse, rate of major adverse cardiovascular events (MACE rate, including cardiovascular death or stroke)
Time frame: 12 months
Plan to share: Yes — All IPD that underlie results in a publication will be available for interested parties.
Supporting information: Study protocol, Sap, Csr
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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