CliNIcal SCEnarios and Pathophysiological Features of Patients With Atrial Fibrillation: a Long Term Prospective Study (NICE-AF Study)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Policlinico Casilino ASL RMB
- Enrollment
- 5000
- Primary Endpoint
- Rate of Atrial Fibrillation recurrences
- Status
- Not yet recruiting
- Last Updated
- 6 years ago
Overview
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.
Investigators
Leonardo Calò, MD
Professor, FESC
Policlinico Casilino ASL RMB
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Rate of Atrial Fibrillation recurrences
Time Frame: 5 years
frequency distribution
Number of participants with Major Adverse Cardiac Events (MACE)
Time Frame: 5 years
frequency distribution
Rate of thromboembolic events
Time Frame: 5 years
frequency distribution
Rate of bleeding events
Time Frame: 5 years
frequency distribution of minor, major and fatal bleedings
Secondary Outcomes
- Rate of participants socio-demographic characteristics(baseline and 5 years)
- Rate of participants with comorbidities(baseline and 5 years)
- Rate of participants with Heart diseases(baseline and 5 years)
- Rate of patients with Atrial Fibrillation secondary to triggers and/or autonomic system imbalance and/or modifiable factors(baseline and 5 years)
- Describe imaging parameters (echocardiogram and cardiac magnetic resonance)(baseline and 5 years)
- Concentration of laboratory biomarkers(baseline and 5 years)