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| Name | Class |
|---|---|
| University of Milan | OTHER |
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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
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Markers of inflammation and fibrosis | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of subjects with AF undergoing ablation who have a reduction of inflammatory burden following treatment. | 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). | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of subjects with AF undergoing ablation who show improvement in clinical terms and in the arrhythmia recurrence rate. | 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 | One year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Paroxysmal or Persistent Atrial Fibrillation
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefano Carugo, MD | Contact | +390255033532 | stefano.carugo@policlinico.mi.it |
| Name | Affiliation | Role |
|---|---|---|
| Stefano Carugo, MD | IRCCS Fondazione Cà Granda Ospedale Maggiore Policlinico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | Recruiting | Milan | 20122 | Italy |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D007249 | Inflammation |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Blood aliquot will be analyzed for the evaluation of markers of atrial inflammation and fibrosis 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.
| Relationship between the degree of inflammation and atrial fibrosis and the degree of atrial fibrosis detected by electroanatomical mapping. | 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) | One year |