cliNIcal sCEnarios and Pathophysiology of Atrial Fibrillation

Study Overview
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Brief Summary
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Atrial fibrillation (AF) remains the most common sustained cardiac arrhythmia with prevalence and incidence continuously increasing worldwide. Current guidelines propose an etiological, symptom-based classification of the arrhythmia and mainly focused on its duration with consequent rhythm or rate-control strategies. Moreover, risk scores for atherothrombotic systemic or hemorrhagic events related to atrial fibrillation are principally based on patients cardiovascular history and risk factors. This approach do not consider relevant pathophysiological aspects that may play a pivotal role in triggering or perpetuating the arrhythmia, especially at its first occurrence. At this point, a crucial step would be deeply investigating AF clinical and pathophysiological features to guide a tailored diagnostical and therapeutic approach. Indeed, early recognition and proper characterization of triggers, substrates, autonomic system imbalance and modulating factors (drugs, electrolytes, etc) are of the utmost importance for AF care and management. Therefore, this large scale prospective observational study aims to evaluate clinical and pathophysiological features of patients with symptomatic and asymptomatic atrial fibrillation in different scenarios to understand possible distinctive characteristics warranting a personalized approach to the arrhythmia.

Official Title
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CliNIcal SCEnarios and Pathophysiological Features of Patients With Atrial Fibrillation: a Long Term Prospective Study (NICE-AF Study)

Conditions
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Atrial Fibrillation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with electrocardiographic diagnosis of Atrial Fibrillation (New Onset, Paroxysmal, Persistent, Long Standing Persistent and Permanent) admitted to the Emergency Room and/or Cardiology Department /ambulatory care center of our Hospital Age >18 years old Patients who can give their written informed consent. Exclusion Criteria: Age <18 years old Patients who cannot give their written informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Atrial Fibrillation recurrences | frequency distribution | 5 years | 
| Number of participants with Major Adverse Cardiac Events (MACE) | frequency distribution | 5 years | 
| Rate of thromboembolic events | frequency distribution | 5 years | 
| Rate of bleeding events | frequency distribution of minor, major and fatal bleedings | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of participants socio-demographic characteristics | Frequency distribution: age, gender, race, occupation, life-style, diet, physical activity, alcohol consumption | baseline and 5 years | 
| Rate of participants with comorbidities | Frequency distribution: hypertension, heart failure, diabetes mellitus, kidney failure, dyslipidemia, lung diseases, thyroid disorders, gastrointestinal and liver disorders, hematological diseases, neoplasms, autoimmune disorders | baseline and 5 years | 
| Rate of participants with Heart diseases | frequency distribution: vascular diseases, valvular problems, cardiomyopathies, arrhythmias, family/genetic history of cardiovascular disease | baseline and 5 years | 
| Rate of patients with Atrial Fibrillation secondary to triggers and/or autonomic system imbalance and/or modifiable factors | Frequency distribution of patients in which atrial fibrillation was clearly related to adrenergic tone imbalance and/or vagal tone imbalance and/or secondary to modifiable factors | baseline and 5 years | 
| Describe imaging parameters (echocardiogram and cardiac magnetic resonance) | Left ventricle, right ventricle, right and left atrium and valves: morphologies, volumes, dimensions and function | baseline and 5 years | 
| Concentration of laboratory biomarkers | Complete Blood cell count with differential; Interleukin-1, Interleukin-6, High sensitivity C Reactive protein | baseline and 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, pathophysiology, triggers, substrates, autonomic system