Arrhythmia, Atrial Fibrillation, Inflammation, Marker of Inflammation
Conditions
Brief summary
It is a non-pharmacological (biological), spontaneous observational study. The main objective is to evaluate the correlation between inflammation markers and local adiposity, clinical risk factors and their possible variation following an AF ablation procedure
Detailed description
The study includes the execution of a sample for each time point for the evaluation of inflammation and fibrosis markers identified so far in the literature, such as Interleukin 6, N-terminal propeptide of procollagen type 1 (P1NP), chitinase-3-like protein 1 (YKL-40), tumor necrosis factor (TNF-alpha), GlycA, proprotein convertase subtilisin/kexin type 9 and omega-3 fatty acids.
Interventions
DIAGNOSTIC_TESTMarkers of inflammation and fibrosis
Will be analyzed the following inflammation markers: Interleukin 6, N-terminal propeptide of type 1 procollagen (P1NP), chitinase-3-like protein 1 (YKL-40), tumor necrosis factor (TNF-alpha), GlycA, proprotein convertase subtilisin/kexin type 9 and omega-3 fatty acids.
Sponsors
University of Milan
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Paroxysmal or persistent AF; * Patients undergoing ESC/ERAH(European Society of Cardiology/European Heart Rhythm Association) approved catheter ablation procedures; * Aged between 18 and 85 years; * Ability to provide informed consent for study participation.
Exclusion criteria
* Age \> 85 years or \< 18 years; * Presence of left auricular thrombosis on pre-procedural transesophageal echocardiogram; * NYHA functional class IV; * Left ventricular ejection fraction \<30%; * Myocardial infarction or unstable angina or recent coronary artery bypass graft (\<6 months); * Significant co-morbidity, such as cancer, severe renal failure requiring dialysis, severe obstructive pulmonary disease, cirrhosis, with a life expectancy of less than 12 months; * Presence of contraindications to the procedure; * Inability to provide informed consent for study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of subjects with AF undergoing ablation who have a reduction of inflammatory burden following treatment. | One year | Outcome measured through biochemical analyzes conducted on the patient: interleukin 6 (pg/ml), procollagen type 1 N-terminal propeptide (µg/l), chitinase-3-like protein 1(ng/ml), tumor necrosis factor -TNF-alpha - (pg/ml), GlycA (mmol/mol). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of subjects with AF undergoing ablation who show improvement in clinical terms and in the arrhythmia recurrence rate. | One year | Identify how many AF patients undergoing ablation have a reduction in related symptoms such as shortness of breath, feeling tired and weakness. The patient will answer an EQ-5D-5L questionnaire for symptom assessment |
| Relationship between the degree of inflammation and atrial fibrosis and the degree of atrial fibrosis detected by electroanatomical mapping. | One year | Relationship between the degree of inflammation and atrial fibrosis detected through biochemical analyzes conducted on the patient: interleukin 6 (pg/ml), procollagen type 1 N-terminal propeptide (µg/l), chitinase-3-like protein 1(ng/ml), tumor necrosis factor -TNF-alpha - (pg/ml), GlycA (mmol/mol) and the degree of atrial fibrosis detected on mapping electroanatomical (voltage map) |
Countries
Italy
Contacts
Primary ContactStefano Carugo, MD
Outcome results
None listed