cliNIcal sCEnarios and Pathophysiology of Atrial Fibrillation
- Conditions
- Atrial Fibrillation
- Registration Number
- NCT04320134
- Lead Sponsor
- Policlinico Casilino ASL RMB
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 5000
- 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.
- Age <18 years old
- Patients who cannot give their written informed consent.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of Atrial Fibrillation recurrences 5 years frequency distribution
Number of participants with Major Adverse Cardiac Events (MACE) 5 years frequency distribution
Rate of bleeding events 5 years frequency distribution of minor, major and fatal bleedings
Rate of thromboembolic events 5 years frequency distribution
- Secondary Outcome Measures
Name Time Method Rate of participants socio-demographic characteristics baseline and 5 years Frequency distribution: age, gender, race, occupation, life-style, diet, physical activity, alcohol consumption
Rate of participants with comorbidities baseline and 5 years Frequency distribution: hypertension, heart failure, diabetes mellitus, kidney failure, dyslipidemia, lung diseases, thyroid disorders, gastrointestinal and liver disorders, hematological diseases, neoplasms, autoimmune disorders
Rate of participants with Heart diseases baseline and 5 years frequency distribution: vascular diseases, valvular problems, cardiomyopathies, arrhythmias, family/genetic history of cardiovascular disease
Rate of patients with Atrial Fibrillation secondary to triggers and/or autonomic system imbalance and/or modifiable factors baseline and 5 years 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
Describe imaging parameters (echocardiogram and cardiac magnetic resonance) baseline and 5 years Left ventricle, right ventricle, right and left atrium and valves: morphologies, volumes, dimensions and function
Concentration of laboratory biomarkers baseline and 5 years Complete Blood cell count with differential; Interleukin-1, Interleukin-6, High sensitivity C Reactive protein